ProMed Pharma Press Release April 2022

ProMed Pharma announces a preclinical rat study to assess pharmacokinetics of a novel long-acting contraceptive implant

Bioresorbable implant aims to address key unmet needs for
family planning at an affordable price in low and middle
income (LMIC) settings

PLYMOUTH, MINNESOTA, UNITED STATES, April 19, 2022
/EINPresswire.com/ -- ProMed Pharma is pleased to
announce the initiation of preclinical evaluation of a novel
fully resorbable contraceptive implant. The implant,
developed in a project funded by the Bill & Melinda Gates
Foundation, aims to address key unmet needs for family
planning at an affordable price in low and middle income
(LMIC) settings.

Commercially available contraceptive implants, while safe
and highly effective, require removal by trained health care
providers any time the user wants to discontinue the
method, including when pregnancy is desired, or when the
implant reaches the end of its effectiveness. This
requirement imposes a strain on resources in LMIC
settings.

The implant being developed by ProMed is specifically designed to address the needs of LMIC settings.
First, it aims to expand women’s contraceptive options by providing 18 months of contraception by long-term release of levonogestrel. This duration fills the gap between that offered by existing injectables and longer-acting methods such as non-erodible implants.
Second, the implant is fully biodegradable, eliminating the need for women to return to medical clinics for removal at the end of the period of effectiveness.
Finally, the implant, which comprises a levonogestrel-releasing outer sheath surrounding a drug-free polymer core, is designed to retain sufficient mechanical integrity to allow removal if or when desired. Removability is important to respond to women’s needs, such as in cases where pregnancy is desired prior to exhaustion of the contraceptive.

The preclinical evaluation of the implants follows selection of four lead formulations combining levonogestrel with cost-effective, commercially available biopolymers that yield near-linear release without the need of a rate controlling membrane. The preclinical study will evaluate the pharmacokinetics of levonogestrel, establish duration of removability, and track length of biodegradation of the designs. The results will allow further narrowing of formulations for clinical evaluation.

Dr. James Arps, Director of Business Development at ProMed, noted “the implant designs have shown promising mechanical integrity and drug release profiles based on in vitro tests to date and have a form factor which is similar if not superior to other implants on the market.” The study will be carried on for a minimum of 6 months with the option of gathering drug release and polymer degradation data up to 1.5 years.

About ProMed Pharma:

ProMed Pharma specializes in the molding and extrusion of drug-loaded silicones, thermoplastics, and bioresorbable materials, leveraging this expertise to manufacture long-term implants and combination devices under cGMP. Working with both established and early stage companies, we utilize robust manufacturing processes for controlled release of APIs utilizing a variety of materials. From clinical trial materials to commercial products, ProMed supports
pharmaceutical and medical device companies developing controlled release formulations including subcutaneous, orthopedic, cardiovacular, and ophthalmic implants, intravaginal rings, and steroid-eluting combination components. The company has facilities in Plymouth and Maple Grove, Minnesota. Please visit www.promedpharmallc.com for more information.

James Arps
Promed Pharma
+1 763-331-3800
email us here
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DFM Checklist for Medical Manufacturing

Injection molding and other medical manufacturing processes are often complex and peppered with potential pitfalls. Fortunately, nearly all of these potential issues can be resolved with a highly competent design. Achieving the best design the first time around is crucial as there is a lot at stake. If OEMs do not get the design right, product rejection rates will increase, productivity will decline, and a host of other issues will ensue – all negatively impacting the bottom line. Additionally, modifying a product or mold design during the production stage can be very costly – so it is worth the time to get the design phase right.

One approach used in medical manufacturing to ensure the best design is Design for Manufacturing, or DFM. This is the process of designing products for ease of manufacturing as well as creating a better, more cost-effective product. DFM is a vital product development step that looks to simplify and optimize the design to ensure high quality and efficiency during production.

One apThe DFM process should occur early in the design phase of any molding project and should engage key parties including designers, tool fabricators, raw material suppliers, manufacturers, and other stakeholders. The goal is to tap into the experience of each of these experts. The team will scrutinize the current design from many angles with the goal of identifying a more cost-effective solution that maintains excellent quality.

How does the DFM Process Add Value?

Simply stated, OEMs need to ensure the part is as easy to manufacture as possible. This will result in more efficient production, better quality, and lower cycle times. Below are some ways OEMs gain value from the Design for Manufacturing process.

· Save Significant Cost and Time: OEMs are often in a rush to get a new product to market so it is tempting to shorten – or even skip – the DFM process. However, it is important to keep in mind that changes to the design become exponentially more expensive and timely to implement as the product advances through the life cycle. A thorough DFM upfront will allow any optimizations to be made or issues to be resolved before the changes significantly impact the project timeline or budget.

· Optimize Functionality and Aesthetics: tooling for molding projects is often expensive to fabricate and costly to modify; thus, it is imperative to get the tool design right the first time. If the design is off even by a small margin, the product aesthetics and functionality will be altered. The DFM process often includes computer simulations of the design as well as rapid prototyping so the team can fully visualize the product. Oftentimes, these steps yield valuable insights and design optimizations that would have been lost if the DFM process was not performed – resulting in a more functional and aesthetically-pleasing product.

· Confirm Manufacturability: last but certainly not least, the DFM process ensures the part can be manufactured. This may seem obvious but there are many instances of products reaching production only to realize the part cannot actually be manufactured per its current design – costing OEMs valuable time, money, and resources

ProMed’s Approach to DFM

To avoid this situation, OEMS should team up with an experienced medical manufacturing partner, like ProMed, that has DFM expertise. ProMed’s design and manufacturing teams are integrated to allow manufacturability issues to be identified and addressed during the design process instead of after the tooling is fabricated – saving customers significant development time and cost as well as innumerable headaches. At ProMed, we works with our customers throughout the product life cycle, providing a cost-effective solution that meets the customer’s needs.

LSR is a versatile silicone that has a wide range of end-uses from medical devices to consumer goods to electronics to automotive. There are several types of LSR that can be manufactured such as medical, self-lubricating, conductive, flame-retardant, and radio opaque. The type of LSR produced is determined by the additives incorporated during the manufacturing process. Additionally, LSR is available in different grades, namely medical, food, and industrial. Given its versatility, it is not surprising that the worldwide demand for LSR continues to grow.

LSR has excellent properties, such as a low viscosity and low shrink rate, that make it a great choice for silicone injection molding and the manufacturing of complex products and intricate parts. One of the benefits of LSR is that it cures faster than most other rubber materials; additionally, due to the highly automated nature of silicone injection molding and the potential for 24/7 manufacturing, high volumes of LSR products can be produced in a short period of time – adding to its popularity.

A key benefit of LSR’s lower viscosity is that it is easier to mix additives into. Additives that can readily be incorporated into a batch of LSR include colorants, desiccants, barium, and pharmaceuticals such as hormones or steroids. For these reasons, LSR is a great option for medical devices such as combination products. The low viscosity of LSR and the temperatures needed to vulcanize LSR are usually low enough that significant degradation of compounded substances, like Active Pharmaceutical Ingredients (APIs) that are used in combination products, can be avoided.

While LSR has many attractive properties, its biocompatibility is outstanding. LSR has demonstrated superb compatibility with human tissue and body fluids, and is resistant to bacteria growth. Medical grades of LSR are temperature resistance and can easily sterilize, which makes them compatible with various medical devices and accessories such as implantable devices, liquid feeding bottles, dialysis filters, and oxygen mask instruments.

Looking for a proven and reliable medical manufacturing partner for your next silicone injection molding project?

Contact the professionals at ProMed to learn more about our range of medical manufacturing solutions and the various silicone materials we utilize.

DFM Checklist for Medical Manufacturing

There are many factors to consider when designing a molded product for the healthcare sector. Below is an example of a DFM checklist that lists key design consideration for an injection molding project. These are topics that OEMs should discuss with their medical manufacturing partner to ensure each of these items is considered in the product design. This is not a comprehensive list but these are some of the most common design parameters that will help ensure a robust design and a successfully molded product. The DFM checklist for your project can be customized to meet the specifics of your application. Visit our website for more medical manufacturing design considerations regarding material selection and part functionality.

· Simplification:

o Can the product size or geometry be simplified or standardized?

o Can complex features such as undercuts or sharp corners be simplified or removed?

o Are all specified tolerances necessary, and which dimensions/tolerances are critical?

· Part thickness:

o Can the part be made to have a uniform thickness throughout?

o Check for thick areas of the part that could result in sinks and voids

o Check for thin areas of the part that could result non-fill

· Part Draft:

o Does sufficient draft exist? Is draft in the right direction and location for a good parting line?

o If texture is being used, is there enough draft to release the part?

· Gate location:

o Can the gate be located in a thick area of the part?

o Will the gate seal at the right time?

o Are multiple gates needed?

· Material considerations:

o Will the material have flow concerns such as excessive shear?

o If the resin does not flow well, are long or thin flow lengths needed?

o Is the fiber orientation correct?

· Operating conditions to consider:

o Maximum pressure during filling and packing

o Clamp force profile

o Fill pattern – is there a potential for material solidification, voids, or hot spots?

o Temperature profile

o Venting temperature - is there a potential for air traps?

· Defects:

o Consider the potential for flash, weld lines, sink marks, short shots, burn marks, shrinkage, warpage, etc.

· Tooling: potential for tool integrity concerns such as thin steel?

About ProMed

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. Over time, we broadened our product offerings to include assembly, micro-molding of highly engineered plastics, and combination products. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

We can identify the right manufacturing solution for any project. We have extensive experience in a wide range of injection molding techniques including:

· Automated Silicone Injection Molding

· Multi-cavity tooling

· Micro molds and micro molding

· Servo-controlled de-molding capabilities

· Insert molds, overmolds, and automation integration

· Transfer molding

· Compression molding

Click here to see why ProMed is your silicone injection molding partner. Contact ProMed today at 763-331-3800 to discuss your next silicone injection molding project.


Common Materials for Silicone Injection Molding

MediSilicone injection molding is a cost-effective manufacturing solution that many OEMs rely on for high-quality, efficient production. This method of manufacturing is very common within the medical sector and has several benefits compared to other molding processes. For example, silicone injection molding is a good choice for a wide range of part sizes, materials, and colors – including highly intricate and complex parts. This method produces products that are virtually identical from part to part which provides excellent brand consistency and part reliability during high volume runs, which is especially crucial for products used in the medical industry. The high reproducibility of silicone injection molding also allows for production to be scaled up to very large volumes, resulting in low costs per unit.

Common Silicones for Injection Molding: LSR and HCR

Silicone elastomers have long been a popular material for silicone injection molding due to their highly desirable mechanical and physical properties. Silicones have excellent durability, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, a wide temperature range, and compatibility with many sterilization methods. Furthermore, silicone is compatible with human tissue and body fluids, has a very low tissue response when implanted, and does not support bacteria growth – making it a perfect option for implants due to its excellent biocompatibility.

Silicone elastomers are primarily available in two forms for medical manufacturing: Liquid Silicone Rubber (LSR) and High Consistency Rubber (HCR). LSR and HCR are both used in medical manufacturing. While HCR and LSR have several similarities, viscosity is a key differentiator and often impacts the decision on which material is utilized for a given silicone injection molding project. The following provides an overview of both elastomers and when each should be utilized.

What is Liquid Silicone Rubber (LSR)?

Liquid Silicone Rubber (LSR) is a platinum-cured elastomer. LSR is a newer silicone technology and starts out as a 2-part liquid that cures into a solid form when mixed. LSR generally comes in buckets and has a longer shelf life than HCR.

LSR is a versatile silicone that has a wide range of end-uses from medical devices to consumer goods to electronics to automotive. There are several types of LSR that can be manufactured such as medical, self-lubricating, conductive, flame-retardant, and radio opaque. The type of LSR produced is determined by the additives incorporated during the manufacturing process. Additionally, LSR is available in different grades, namely medical, food, and industrial. Given its versatility, it is not surprising that the worldwide demand for LSR continues to grow.

LSR has excellent properties, such as a low viscosity and low shrink rate, that make it a great choice for silicone injection molding and the manufacturing of complex products and intricate parts. One of the benefits of LSR is that it cures faster than most other rubber materials; additionally, due to the highly automated nature of silicone injection molding and the potential for 24/7 manufacturing, high volumes of LSR products can be produced in a short period of time – adding to its popularity.

A key benefit of LSR’s lower viscosity is that it is easier to mix additives into. Additives that can readily be incorporated into a batch of LSR include colorants, desiccants, barium, and pharmaceuticals such as hormones or steroids. For these reasons, LSR is a great option for medical devices such as combination products. The low viscosity of LSR and the temperatures needed to vulcanize LSR are usually low enough that significant degradation of compounded substances, like Active Pharmaceutical Ingredients (APIs) that are used in combination products, can be avoided.

While LSR has many attractive properties, its biocompatibility is outstanding. LSR has demonstrated superb compatibility with human tissue and body fluids, and is resistant to bacteria growth. Medical grades of LSR are temperature resistance and can easily sterilize, which makes them compatible with various medical devices and accessories such as implantable devices, liquid feeding bottles, dialysis filters, and oxygen mask instruments.

Looking for a proven and reliable medical manufacturing partner for your next silicone injection molding project?

Contact the professionals at ProMed to learn more about our range of medical manufacturing solutions and the various silicone materials we utilize.

What is High-Consistency Rubber (HCR)?

Another common elastomer for silicone injection molding is High-Consistency Rubber, or HCR. It should be noted that the terms HCR and HTV, which stands for High Temperature Vulcanization, are often used interchangeably and refer to the same silicone material; for the purpose of this article, we will use the acronym HCR.

HCR is a type of silicone elastomer comprised of long polymer chains with a very high molecular weight. It is cured at high temperatures with a platinum catalyst or peroxides. HCR is known for its gummy consistency that is similar to peanut butter, and mostly comes in partially vulcanized sheets.

HCR has many desirable properties such as excellent aging resistance, thermal stability, electrical properties, mechanical strength, elongation, and hardness. For these reasons, HCR is a good material for a broad range of applications within medical manufacturing. Due to its higher viscosity compared to other elastomers such as LSR, HCR is typically processed using compression and transfer molding methods, but is also utilized for silicone injection molding projects.

HCR takes longer to cure than many other molding materials. A longer cure time results in a longer silicone injection molding cycle time. To improve project economics, HCR molds often have a large number of

cavities in order to accommodate the longer cycles and still achieve the desired production volume for each cycle – resulting in a more cost-effective solution on a per unit basis.

Which Silicone is Best for My Injection Molding Project?

Medical device OEMs often face a tough decision: should we use HCR or LSR for our silicone injection molding project? For companies already using HCR to manufacture medical components, it may make sense to continue using this elastomer especially since the initial capital equipment costs have already been made. For new product development, however, LSR is often the best choice given the lower capital costs and labor associated with processing this silicone. Due to its lower cost and versatility with formulations, companies often prefer LSR over HCR – but the decision should be made on a case-by-case basis. This is why it is important to team up with an experienced partner, such as ProMed, who will guide you through the selection process to ensure the right material is chosen for your silicone injection molding project.

About ProMed

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. Over time, we broadened our product offerings to include assembly, micro-molding of highly engineered plastics, and combination products. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

We can identify the right manufacturing solution for any project. We have extensive experience in a wide range of injection molding techniques including:

· Automated Silicone Injection Molding

· Multi-cavity tooling

· Micro molds and micro molding

· Servo-controlled de-molding capabilities

· Insert molds, overmolds, and automation integration

· Transfer molding

· Compression molding

Click here to see why ProMed is your silicone injection molding partner. Contact ProMed today at 763-331-3800 to discuss your next silicone injection molding project.


silicone injection, molding silicone, medical manufacturing companies

Transfer Molding 101

From surgical instrument handles and catheters, to drug-eluting implants and stents, medical manufacturing companies employ a variety of techniques to produce medical devices and components used in the healthcare sector. The following provides an overview of the transfer molding process as well as the materials medical manufacturing companies typically utilize with this method.

What is Transfer Molding?

Transfer molding is a proven processing method that has been used by medical manufacturing companies for a long time. This technique produces high quality silicone molded products including parts with complex geometries and intricate features. This method is similar to injection molding and employs many of the same elements: a heated mold cavity, sprue channels, and an external actuator that pushes the molten material into the mold. In transfer molding, an open chamber called the pot is filled with the material to be molded. Then, a plunger pushes on this material and squeezes it into the mold, which is connected to the pot via channels. As the name implies, this method of manufacturing “transfers” material from the exterior of a mold through the sprue and runner system into the cavities of the mold.

While transfer molding and injection molding have some similarities, there are some key differences. Transfer molding typically uses higher pressures than injection molding to ensure the mold is adequately filled. Additionally, the material used in transfer molding may begin the process as a solid or liquid, in contrast to injection molding that utilizes only liquids.

Transfer molding may also be combined with overmolding or insert molding to manufacture the desired final part. These techniques can be used together to create a composite product which has a plastic or silicone layer molded over some or all of a different material. Both overmolding and insert molding are great for joining parts to moldable materials without using adhesives or mechanical fasteners.

Looking for a medical manufacturing partner that offers a wide range of silicone molding solutions?

Contact the team at ProMed to learn more about our capabilities and the various silicone molding techniques we employ.

What Materials are the Best Fit for Transfer Molding?

Medical manufacturing companies have long relied on silicone for molding processes. Silicone elastomers are a good fit for medical manufacturing due to their durability, ease of molding by many methods, wide temperature range, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, and compatibility with many sterilization methods. Silicone has unique material characteristics that enable parts to be molded with intricate features, undercuts, finishes, and tight tolerances. At ProMed, we specialize in silicones for medical manufacturing and offer custom compounding to meet the performance requirements of your design. From concept to existing production, whether your part is simple or complex, our highly qualified technology staff guide you through the project.

Silicone raw materials for medical manufacturing are available in two main forms: Liquid Silicone Rubber (LSR) and High Consistency Rubber (HCR). When it comes to silicone injection molding, LSR is typically the silicone of choice. Due to its higher viscosity and more challenging handling properties, HCR is typically processed using transfer or compression molding methods. Additionally, transfer molding can be used for any volume of production but is often most cost-effective for low to medium size runs.

About ProMed

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

We can identify the right manufacturing solution for any project. We have extensive experience in a wide range of injection molding techniques including:

  • Automated Injection Molding
  • Multi-cavity tooling
  • Micro molds and micro molding
  • Servo-controlled de-molding capabilities
  • Insert molds, overmolds, and automation integration
  • Transfer molding
  • Compression molding

Contact ProMed today at 763-331-3800 to discuss how we can help with your next project!


Why A Skilled Injection Molding Partner Matters

There are many factors to consider when choosing an injection molding partner. One area to examine is the skill of the molding partner. This may seem like an obvious consideration but it is crucial that OEMs consider the breadth and depth of capabilities of any molding partner being considered.

Simply put, the skill and capabilities of an injection molding partner matters as not all manufacturers are equipped to offer the same solutions. For this reason, OEMs must partner with a manufacturer, like ProMed, that has the proven experience, facilities, and know-how to safely and successfully complete injection molding projects. Below are some of the benefits of working with a skilled injection molding partner, and why skill matters. It should be noted that all of the advantages below lead to more cost-effective solutions and higher levels of customer satisfaction.

  • Broad Material Options: some injection molders specialize in specific material types, so it’s important to know what your potential partner is capable of, and also what they specialize in. It is crucial that OEMs team up with a proven partner, like ProMed, who has experience with a diverse range of materials and will guide you through the selection process to ensure the right material is chosen to achieve the desired final product properties, such as strength, flexibility, and biocompatibility.
  • Able to Achieve Specifications: most OEMs have unique and specific product specifications and it is important that molding partners understand and are able to comply with those specifications. In nearly every case, a skilled injection molding partner can manufacture your part without significant specification sacrifices. Partners should readily collaborate with OEMs, providing alternatives to specification challenges as well as design suggestions to save time and money. If this collaboration is not happening, you have not found the right molding partner.
  • Superb Quality: partnering with a skilled injection molder ensures the necessary production planning occurs in order to meet the requisite regulatory, quality, and commercial standards. The ProMed work force is highly specialized in the manufacturing and quality requirements of medical products. We are an approved, certified supplier to many of the top medical device manufacturers in the world. Click here to learn more about our commitment to quality as well as our ISO clean rooms and various certifications.

Looking for a skilled molding partner that consistently delivers high-quality products?
Contact the ProMed team today to discuss our injection molding solutions.

  • Advanced Molding Technologies: a skilled injection molding partner not only has a proven team of professionals, but also employs state-of-the-art technologies. At ProMed, we utilize cost-effective, high-end molding technology to keep operating expenses down while producing parts with an extremely high level of precision and repeatability. Our tools are designed and manufactured to exacting tolerances. Expert toolmakers use high-tech design software and machining centers to produce molds that are durable and dimensionally repeatable from cavity-to-cavity, part-to-part.
  • Future Growth Opportunities: as noted, not all injection molding partners offer the same solutions – and what you need today may not be what you need tomorrow. Skilled injection molding companies with a broad range of capabilities and offerings are better positioned to provide support as your business evolves and grows over time.

ProMed Molding Capabilities

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms. We can identify the right manufacturing solution for any project and have extensive experience in a wide range of molding techniques including:

  • Automated Injection Molding
  • Multi-cavity tooling
  • Micro molds and micro molding
  • Servo-controlled de-molding capabilities
  • Insert molds, overmolds, and automation integration
  • Transfer molding
  • Compression molding

Contact ProMed today at 763-331-3800 to discuss how we can help design your next molded project for success.


Silicone Injection Molding’s Impact on the Biopharmaceutical Industry

There are many similarities between traditional pharmaceuticals and biopharmaceuticals. However, the key distinction is that biopharmaceuticals are products derived from biological sources and are manufactured in living organisms such as bacteria or human cells. Pharmaceuticals, on the other hand, are synthetic and are manufactured via chemical synthesis.

Biopharmaceutical products are employed across the healthcare industry to treat various diseases and other conditions. There is a myriad of different biopharmaceutical applications including vaccines, allergenics, hormones, blood factors and components, and gene and cell therapies. In some cases, biopharmaceuticals are able to more effectively treat a patient than traditional pharmaceuticals. For this reason, the biopharmaceutical industry continues to expand due to continuous innovation and demand, pushing the boundaries of science. With this growth, the manufacturing of biopharmaceutical products must also advance – highlighting the impact of silicone injection molding on the biopharmaceutical industry. Silicone injection molding processes are able to produce high volumes of products, such as syringes and implants, that make the delivery and administration of biopharmaceuticals easier, safer and more efficient. Simply put, the biopharmaceutical industry is directly linked to – and heavily relies on – silicone injection molding, and will continue to do so as both industries grow.

Why are Silicones a Good Fit for Biopharmaceuticals?

Silicone has long been a popular material for medical device manufacturers, and many of the benefits of using silicones in traditional pharmaceuticals are the same as in the biopharmaceutical industry.

Silicone is an excellent choice for biopharmaceutical products due to its durability, wide useful temperature range, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, and compatibility with many sterilization methods. But the key characteristic that makes silicone the perfect match for biopharmaceuticals is its biocompatibility.

Biopharmaceutical devices and products often come in contact with the human body – either externally on a patient’s skin or internally as an implant that contacts tissue and fluids. Silicone is compatible with human tissue and body fluids, has a very low tissue response when implanted, and does not support bacteria growth. Simply put, medical grade silicones are unmatched in their biocompatibility, making silicones an excellent option for the biopharmaceutical industry. Additionally, medical grade silicones are often processed in special facilities called cleanrooms that reduce the potential for contamination. For example, all of ProMed’s manufacturing facilities are equipped with certified class 10,000 / ISO Class 7 cleanrooms, demonstrating a strong commitment to quality.

One application where medical-grade silicones really shine is drug-eluting implantable devices. Before molding, silicones can be compounded with biopharmaceuticals, such as hormones, which can then be steadily released into a targeted area of the patient’s body over time once the molded implant is inserted. Drug-eluting implants are able to maintain the desired dosage in the patient much more consistently and over a longer period of time than both pills and injections. Also, since the implant can usually be inserted near the targeted organ or tissue, lower doses are needed because the active biopharmaceutical ingredients do not need to spread throughout the entire body before reaching the targeted area. Silicone implantables are just one example of the impact silicone injection molding has on the biopharmaceutical industry.

Have a biopharmaceutical project that requires high quality and reproducibility?
Contact the ProMed team to discuss our silicone injection molding solutions.

Why is Silicone Injection Molding Best for the Biopharmaceutical Industry?

Silicone injection molding has several benefits compared to other molding processes, and below are some of its key advantages. Due to the high volumes required for many devices and products used in the biopharmaceutical sector, injection molding is often the most cost-effective manufacturing solution.

  • High Quality & Very Reproducible: silicone injection molding produces products that are virtually identical from part to part which provides excellent brand consistency and part reliability during high volume runs – this is especially crucial for parts and devices used in the biopharmaceutical industry. High reproducibility also allows for production to be scaled up to very large volumes, resulting in low costs per unit after the upfront equipment set-up costs are paid.
  • Excellent Versatility: silicone injection molding is a good choice for a wide range of part sizes, materials, and colors. Additionally, injection molding allows for the use of multiple materials simultaneously, allowing for a high degree of customization.
  • Able to Produce Complex Parts: silicone injection molding is typically performed at high pressure which forces the silicone into small crevices in the mold (that other molding processes are unable to reach), enabling the production of small, intricate and complex parts for the biopharmaceutical sector.
  • Efficient Production: silicone injection molding is a very fast process that generates high-output production compared to other molding methods, making injection molding a more efficient and cost-effective solution.
  • Low Waste Generation: silicone injection molding manufactures smooth products that have minimal finishing requirements after removal from the mold – resulting in less waste generation compared to other molding techniques.

ProMed Pharma’s Capabilities

ProMed Pharma is a leading contract manufacturer of polymer-based drug releasing molded dosage forms and combination device components, such as drug-eluting products. Working with both established and early-stage medical device and pharmaceutical companies, we develop robust manufacturing processes and platforms for extended drug release from a variety of materials, including silicones and thermoplastics.

We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics – including Liquid Silicone Rubber (LSR) that is an excellent option for drug-eluting medical products. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

Contact ProMed today at 763-331-3800 to discuss your next medical molding project.


Why is Silicone a Great Molding Material?

Silicone elastomers have long been a popular material for medical devices and medical device components due to their durability, ease of molding by many methods, wide temperature range, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, and compatibility with many sterilization methods. Furthermore, silicone is compatible with human tissue and body fluids, has a very low tissue response when implanted, and does not support bacteria growth – making it a perfect option for implants due to its excellent biocompatibility. Additionally, medical-grade silicones have undergone stringent purity and biocompatibility testing that make them suitable for short and long-term usage.

Why is Silicone a Great Molding Material?

Silicone elastomers are available in two commercial forms: Liquid Silicone Rubber (LSR) and High Consistency Rubber (HCR). LSR has a lower viscosity than HCR and is, therefore, often processed via injection molding. Due to its higher viscosity and more challenging handling properties, HCR is typically processed using compression and transfer molding methods, which are more labor-intensive. LSR is often the preferred choice given the lower capital costs and labor associated with processing this elastomer. For this reason, this article will focus on the properties that make LSR a great molding material.

LSR has excellent properties and material handling characteristics that make it a great choice for molding. Below is a deeper dive into some of these key properties. It should be noted that there are different grades of silicones with varying material properties; however, the following generally represents most LSR formulations.

  • Low Viscosity: the low viscosity of LSR makes it a great silicone material for making medical devices via injection molding, since the LSR can easily flow into and completely fill molds with relatively low injection pressures, even those with small, complex, or high-tolerance features. A lower viscosity also makes it easier for manufacturers to mix in additives including colorants, desiccants, barium, and pharmaceuticals such as hormones or steroids. For these reasons, LSR is a great option for medical devices such as combination products.
  • Quick Cure Rate: one of the benefits of LSR is that it cures faster than most other rubber materials – in some cases in only seconds. Additionally, due to the highly automated nature of injection molding and the potential for 24/7 manufacturing, high volumes of LSR products can be produced in a short period of time – adding to its popularity.
  • Low Compression Set: this property is a measure of how well a material can resist permanent deformation under a constant strain. LSR has low compression set, meaning LSR products are able to retain their original shape and elasticity even when compressed for long durations.
  • Electrical Resistance: LSR formulations are often used in high-voltage and electrical equipment due to its electrical resistance and ability to act as an insulator. Many materials degrade when exposed to electrical and other environmental stresses over time, however, this is not the case for LSR.
  • Broad Temperature Range: compared to other materials, LSR has excellent thermal stability. LSR blends are able to withstand high temperatures without deforming or melting, making them a great choice for parts for the automotive sector. As for low temperatures, LSR maintains its flexibility and does not become brittle and vulnerable to breaking like thermoplastic elastomers.
  • Chemical Resistance: LSR is chemically inert and is resistant to a variety of chemicals. Its biocompatibility is unmatched, making LSR a great option for medical devices, implantables, and other healthcare applications.
  • Longevity: LSR is known for its resistance to UV, weather, and other environmental conditions that tend to age materials, leading to longer life spans for LSR products.

ProMed’s Silicone Molding Capabilities

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

We can identify the right manufacturing solution for any project. We have extensive experience in a wide range of injection molding techniques including:

  • Automated Injection Molding
  • Multi-cavity tooling
  • Micro molds and micro molding
  • Servo-controlled de-molding capabilities
  • Insert molds, overmolds, and automation integration
  • Transfer molding
  • Compression molding

Contact ProMed today at 763-331-3800 to discuss your next medical molding project.


7 Uses of Implantable Silicone in Healthcare

According to the U.S. FDA, medical implants are devices placed inside or on the surface of the body. Medical implants, or implantables as they are often called, serve many purposes including delivering medication, monitoring body conditions, and supporting organ health. Depending on the application, implants can remain in or on the body for short or long periods of time.

As expected, there are key material considerations for implantables such as biocompatibility, stability, and durability. Medical grade silicones have long been a material of choice for implantables given their range of available durometers, extreme chemical inertness and biocompatibility, and excellent tear and heat resistance. There are various applications for medical grade silicones, and below are 7 uses of implantable silicone in healthcare.

  1. Drug Delivery Implants: when it comes to drug delivery, implantables provide a great benefit to patients over conventional dosage methods. For example, implantable devices provide site specific drug administration where the drug is most needed – this targeted treatment often allows for lower doses, reducing side effects. Additionally, this form of drug dosage is less burdensome to the patient. Examples of drug delivery implantables include treatments for brain tumors, prostate cancer, and uterine fibroids with R&D focused on Parkinson’s disease and schizophrenia.
  2. Cardiac Pacemakers: these implants are considered “active” implantables since they operate with a battery or other electrical supply. Cardiac pacemakers employ electrostimulation to regulate heart beat and rhythm. The electrical signals generated by the device cause the heart muscles to contract, pumping blood through the body. Today’s pacemakers are able to be remotely programmed and monitored by cardiologists, allowing for more patient-specific care.
  3. Stents: stents are a type of silicone implant that is widespread within healthcare, and are categorized as a “static” implantable since the device has no moving parts. One common example of these type of implants is a vascular stent, which is used to preserve and maintain blood flow in the heart. For drug delivery applications, the stent is implanted in the patient’s artery and slowly releases the desired drug over time to target the care exactly where it is needed.
  4. Catheters: silicone catheters function the same as devices made with any other material, and are a good option for patients that may have sensitivities such as latex allergies. There are several applications for catheters in healthcare such as cardiac catheters to drain fluids after heart procedures. Additionally, recent technology advances in catheters include an antimicrobial coating to prevent infections.
  5. Orthopedic: this form of implant is used to mechanically reinforce the spine or restore range of motion in joints such as hips and knees. Silicone is often used in implants that replace or repair diseased or otherwise impaired small joints within the body, such as hands and feet.
  6. Ear and Eye Devices: there are several kinds of silicone implantables for ear and eye applications. For the ears, cochlear implants, hearing aids, and ear plugs are the most common devices. For eyes, silicone can be used in ocular implants, intraocular lenses, and liners for prosthesis.
  7. Valves: silicone is frequently utilized in many different valves within the healthcare sector. Heart valves are often made of silicone due to its biocompatibility and longevity. There are also uses for silicone valves that are external to the body; for example, one-way valves to prevent the reverse flow of blood from a patient when connected to an IV or other means of administering medicine.

ProMed Pharma’s Capabilities

ProMed Pharma is a leading contract manufacturer of polymer-based drug releasing molded dosage forms and combination device components, such as drug-eluting products. Working with both established and early-stage medical device and pharmaceutical companies, we develop robust manufacturing processes and platforms for extended drug release from a variety of materials, including silicones and thermoplastics.

We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics – including Liquid Silicone Rubber (LSR) that is an excellent option for drug-eluting medical products! We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

Contact ProMed today at 763-331-3800 to discuss your next medical molding project.


How Long Do Injection Molds Last?

One of the primary costs of an injection molding project is the tooling. Given the size of the initial investment in the injection mold, OEMs want the mold to last as long as possible and often wonder how long the mold will last. It is important to understand that the lifetime of injection molds is typically measured in production cycles as opposed to time. This approach allows OEMs to determine when the initial tooling cost will be paid off, and if the cost of the tooling is justified based on the number of parts the mold is expected to manufacture.

There are several factors that play a part in injection mold longevity. One key design criteria that predicts tooling life span is mold class, which is indicative of the life expectancy of the mold based on the number of cycles it is designed for.

What is Tooling Mold Class?

The tooling mold class as defined by the Plastics Industry Association sets standards on the physical tool construction and life expectancy. To determine which mold class to proceed with, designers often start with the desired life expectancy and the tool material. For example, if the project has a short life expectancy with a commodity grade material or an engineered grade that is not abrasive, designers can likely start at Class 105 or “prototyping” mold class. As expected, the more cycles required of tooling, the more robust the mold must be, thus, driving up the overall tooling cost. By selecting the appropriate mold class for your application, you can save a significant amount of costs by not over-engineering the tool. Below are descriptions of different mold classes. It should be noted that the following are only general guidelines and OEMs should consult with a trusted injection molding partner, like ProMed, to ensure the right design criteria, including mold class, are selected for your specific project.

  • Mold Class 101: this class is for high volumes and is rated for 1,000,000+ cycles. These molds typically operate with very fast cycle times. Due to the high-volume requirements, these molds are made with the highest quality materials and are the most expensive. These molds can tolerate harsh materials and operating conditions, and are able to achieve tight tolerances.
  • Mold Class 102: this class is rated for no more than one million cycles. This tool is for medium to high volume production and is usually a good option for abrasive materials as well as close tolerance products.
  • Mold Class 103: this mold class is rated for under 500,000 cycles. This is a common mold for low to medium volume production.
  • Mold Class 104: this mold class is rated for under 100,000 Cycles. This tooling is a good option for lower production volumes with non-abrasive materials.
  • Mold Class 105: this class is rated for no more than 500 cycles and is typically for prototype purposes. This tooling is the least expensive.

What Impacts Mold Longevity?

Although mold class is a good basis for designing tooling longevity, there is no method to determine exactly how many cycles a mold will last. However, the factors below each impact the life span of a mold and the life can be maximized for molds that are well cared for.

  • Materials – the life span of an injection mold is significantly impacted by the material of the injection molded products as well as the material of the tooling itself. Molds made of a softer metal, like aluminum, do not generally last as long as harder metal molds such as stainless steel. As for the silicone blend being molded, some formulations contain abrasive or corrosive ingredients, which can wear down the tooling and decrease the life span.
  • Conditions – injection molding manufacturing occurs under a range of operating conditions and some environments are tougher on equipment than others. Additionally, cleanliness and the likelihood for contaminants such as moisture, dust, and debris also impact the life cycle of tooling.
  • Length of Cycles – As a rule of thumb, injection molds tend to last longer when they operate under longer cycle times compared to high-speed production cycles.
  • Proper Maintenance – this is one of the key elements that impact tooling life span yet it is often overlooked. Preventative maintenance and the associated inspections are vital to maximizing the life of injection molds.

ProMed’s Silicone Injection Molding Capabilities

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

We can identify the right manufacturing solution for any project. We have extensive experience in a wide range of injection molding techniques including:

  • Automated Injection Molding
  • Multi-cavity tooling
  • Micro molds and micro molding
  • Servo-controlled de-molding capabilities
  • Insert molds, overmolds, and automation integration
  • Transfer molding
  • Compression molding

Contact ProMed today at 763-331-3800 to discuss your next medical molding project.


Silicone Injection Molding vs. 3D Printing

Silicone injection molding and 3D printing are two excellent manufacturing methods with the same goal: creating a 3D product. However, these two processes are very different, each with its own set of advantages and use cases. The following compares silicone injection molding versus 3D printing. It is imperative that companies understand each of these processes in order to determine which method is best for their specific application. As you will see, in some cases, it may make sense to employ both 3D printing and silicone injection molding on a single project.

What are 3D Printing and Silicone Injection Molding?

Both 3D printing and silicone injection molding start with a digital 3D design but quickly divert down two very different manufacturing paths. 3D printing is a process that builds a three-dimensional object based on a Computer Aided Design (CAD) sketch. 3D printing is one of several technologies under the umbrella of Additive Manufacturing (AM), named as such since it starts from nothing and builds layer by layer of material. The 3D printing machine uses the CAD data to add successive layers of liquid, powder, or other material to manufacture a 3D object. A wide range of materials can be used for 3D printing including metals, plastics, and composites and these are called filament. The equipment required for 3D printing are the spools of filament material and the 3D printer itself, resulting in low upfront capital costs. 3D printing allows manufacturers to fabricate parts on-demand as this process only needs a new CAD input in order to manufacture a new product, and does not require retooling or machine changes. Lastly, 3D printing generates minimal waste since it is an AM method.

As for silicone injection molding, the process begins when silicone is fed into a heated barrel. A screw is used to mix, heat, and transport the silicone toward to the mold. The melted material is then injected through a nozzle into the mold and travels via a gate and runner system into the mold cavity. As the silicone enters the mold, excess air can be released via vents. The pressure and temperature of the mold are maintained to allow the silicone to conform to the desired shape and harden quickly. Once the part is adequately cooled, the mold opens and the part is ejected. The mold is then ready to receive the next charge of silicone. The key equipment necessary for silicone injection molding include the silicone and any additives, an injection molding machine, and the mold which is typically made of a hard metal. A commonly used material in injection molding is LSR, or liquid silicone rubber. Silicone injection molding is a very fast process that generates high-output production compared to other molding methods, making injection molding a more efficient and cost-effective solution. Silicone injection molding produces products that are virtually identical from part to part which provides excellent brand consistency and part reliability.

Is Silicone Injection Molding or 3D Printing Better?

The answer, of course, depends on the specifics of your project. Generally speaking, 3D printing and silicone injection molding do not compete for the same projects as they are each suited for different manufacturing situations. Below are some examples of when each process makes good business sense.

Injection molding is often best suited for production runs with medium to high volumes of an identical product – up to thousands and even millions of parts. Injection molding tooling is often a large expense; thus, larger production runs are necessary to offset the cost of tooling on a price per part basis. Once tooling is fabricated, injection molding is hard to beat in terms of time per part since products are often molded in minutes or even seconds. Injection molding is usually the method of choice for manufacturing parts that will move against other pieces as the surface finish is smooth. Lastly, silicone injection molding is a proven and trusted technology with decades of experience and know-how to rely on.

In general, 3D printing is most cost-effective for lower volume runs including prototypes and small batches. This technique offers customers flexibility and the ability to tweak the design by simply modifying the CAD inputs since no hard tooling changes are required. This method is also attractive when a quick turnround time is necessary as little lead time is necessary and custom tooling is not required.

There are some instances where a combination of 3D printing and silicone injection molding is most cost-effective. For example, 3D printing may be used for prototyping as well as “bridging” the gap between design and full production in order to get products to the market rapidly while the injection molding tooling is fabricated. Then, once the tooling is available, silicone injection molding is employed for full, high volume production.

ProMed’s Molding Capabilities

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

We can identify the right manufacturing solution for any project. We have extensive experience in a wide range of injection molding techniques including:

  • Automated injection molding
  • Multi-cavity tooling
  • Micro molds and micro molding
  • Servo-controlled de-molding capabilities
  • Insert molds, overmolds, and automation integration
  • Transfer molding
  • Compression molding

Contact us today at 763-331-3800 to discuss your next medical molding project.