Category Archive: Blog

ProMed Pharma Press Release April 2022

Posted by Promed on April 27, 2022 7:34 am | Leave a Comment

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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Download the Press Release Here

This press release can be viewed online at: https://www.einpresswire.com/article/569066201
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DFM Checklist for Medical Manufacturing

Posted by Promed on April 26, 2022 8:32 am | Leave a Comment

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:

Can the product size or geometry be simplified or standardized?
Can complex features such as undercuts or sharp corners be simplified or removed?
Are all specified tolerances necessary, and which dimensions/tolerances are critical?

· Part thickness:

Can the part be made to have a uniform thickness throughout?
Check for thick areas of the part that could result in sinks and voids
Check for thin areas of the part that could result non-fill

· Part Draft:

Does sufficient draft exist? Is draft in the right direction and location for a good parting line?
If texture is being used, is there enough draft to release the part?

· Gate location:

Can the gate be located in a thick area of the part?
Will the gate seal at the right time?
Are multiple gates needed?

· Material considerations:

Will the material have flow concerns such as excessive shear?
If the resin does not flow well, are long or thin flow lengths needed?
Is the fiber orientation correct?

· Operating conditions to consider:

Maximum pressure during filling and packing
Clamp force profile
Fill pattern – is there a potential for material solidification, voids, or hot spots?
Temperature profile
Venting temperature – is there a potential for air traps?

· Defects:

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

Posted by Krista Reske on March 23, 2022 8:33 am | Leave a Comment

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.

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.