medical manufacturing, injection molding, silicon injection molding

Medical Manufacturing Explained: What Happens in a Class 10,000 Clean Room?

Medical devices and components for the healthcare industry often come in contact with human skin and tissues, and are even implanted in some cases. For this reason, medical manufacturing typically requires a cleaner, more sterile environment to avoid the potential for contamination that could result in diminished functionality of the product, or lead to infection or other risks for the patient. There are various technologies that medical manufacturers can employ to ensure cleanliness, and one of the most common and effective is a clean room, or cleanroom. ProMed’s manufacturing facilities, for example, are equipped with certified class 10,000 / ISO Class 7 clean rooms, demonstrating a strong commitment to quality.

What is a Clean Room in Medical Manufacturing?

Medical grade silicones are often processed in a very controlled and special facility known as a clean room. These rooms reduce the potential for contamination from dust and airborne microbes such as bacteria or viruses. Clean rooms control contaminants and air quality, and are essential to manufacturing high quality medical products. Clean rooms vary in size from large open spaces to small laboratory rooms. In addition to controlling cleanliness and contaminants, some clean rooms further control conditions such as humidity, air flow, air pressure, temperature, and electrostatic discharge.

The International Organization for Standardization (ISO) establishes the requirements for medical device manufacturing. Maintaining and operating a clean room environment to ISO standards requires excellent processes and procedures. In addition to production, clean room processing includes raw material handling as well as packaging to avoid particulates and other forms of contamination during these steps. Medical manufacturers, like ProMed, that are ISO 13485 certified have demonstrated the capability and know-how to manufacture medical devices under the requisite cleanliness and contamination controls.

Have a medical manufacturing project that requires a class 10,000 clean room?
Contact ProMed to learn more about our advanced facilities and range of silicone injection molding solutions.

What is a Class 10,000 Clean Room?

There are different levels of ISO requirements for medical manufacturing, ranging from ISO 5 to ISO 8. Most medical device manufacturing is categorized as ISO 7. Each ISO level of a clean room has a corresponding class. Clean rooms are categorized by class ranging from 100 to 100,000. The class is based on the number and size of particles permitted per volume of air. For example, an ISO 7 clean room is equivalent to a class 10,000 clean room, which means the facility must have less than 10,000 particles per cubic foot. Special filtration systems within the clean room use HEPA filters, air flow, and other measures to manage the purity of the air to ensure the necessary ISO requirements are met.

In addition to using air filtration to control cleanliness, class 10,000 clean rooms typically require personnel to wear protective equipment ranging from full bunny suits to partial coverings such as shoe covers, laboratory coats, hair nets, safety glasses, and gloves. These measures prevent human contaminants like hair, sweat, or skin from coming in contact with the manufacturing process. Clean rooms are often designed with specific wall and floor materials that are readily cleaned, as well as stainless-steel work tops and sinks. Lastly, some clean room designs include an air shower at the room entrance to reduce the level of contaminants entering the manufacturing space.

At ProMed, 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 clean rooms. Our facilities support silicone injection molding of various medical devices and components including:

  • Surgical instruments
  • Connector boots
  • Grommets
  • Tines

  • Inner/outer seals
  • Suture sleeves
  • Balloons

  • Surgical instruments
  • Connector boots
  • Grommets
  • Tines
  • Inner/outer seals
  • Suture sleeves
  • Balloons

About ProMed Pharma

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 have multiple manufacturing sites, all are certified class 10,000 / ISO Class 7 cleanrooms.

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


medical manufacturing companies, medical component manufacturing, liquid silicone molding

4 Surprising QMS Statistics about Medical Manufacturing Companies

Most medical manufacturing companies know that quality is key. At ProMed, quality is our main driver and is an integral part of every process we undertake. Our quality professionals work hand-in-hand with our manufacturing teams to ensure quality is part of every decision we make. We provide OEMs a reliable and dependable process that yields consistent results. Consistent quality is hard work and requires rigorous, on-going monitoring of every process from purchasing to manufacturing to distribution. But the effort and focus on quality is well worth the reward. Our robust quality control and quality assurance programs ensure uniform, high-quality medical devices, and are one of the reasons ProMed stands out from the competition. Click here to watch a short video about our Quality Management System.

What is a QMS for Medical Manufacturing Companies?

Medical manufacturing companies utilize a Quality Management System, QMS, to manage their quality program. A QMS is a formal system that documents processes, procedures, and responsibilities that pertain to quality. This system addresses the design, production, labeling, distribution, storage, and other aspects related to medical component manufacturing. Medical manufacturing companies utilize the QMS to demonstrate compliance with customer requirements and regulatory regulations from the U.S. FDA as well as standards like ISO 13485.

There are many benefits of a robust QMS program. In addition to meeting the customer and regulatory specifications, a strong QMS often leads to more efficient operations, less waste, and fewer errors – resulting in a lower cost medical component.

Most highly-regulated sectors, like healthcare, require a QMS as part of the product development and registration process. The complexity of the QMS may vary depending on the classification and risk of the medical component. For example, an implantable medical device will typically have more stringent QMS requirements than a single-use medical instrument.

Looking for a medical manufacturing company that consistently delivers high-quality products?

Contact the ProMed team today to discuss our liquid injection molding solutions and our unwavering commitment to quality.

QMS Statistics about Medical Manufacturing Companies

An industry benchmark was recently conducted to test the health of quality management across the medical device industry. Below are 4 surprising QMS statistics about medical manufacturing companies. Based on these statistics and findings, it is clearly important that OEMs partner with a medical manufacturing company, like ProMed, that is truly committed to quality and embeds quality in every aspect of medical manufacturing.

  1. Over two-thirds of medical manufacturing companies surveyed indicated quality is woven into the company culture. The majority of medical manufacturing companies no longer view QMS programs as a “tick the box” activity but as an opportunity to distinguish themselves from the competition.
  2. Responsiveness is a key aspect of any robust QMS program. However, 71% of professionals surveyed indicate the data collected by their quality system is not easily accessible in real-time. It is important that medical manufacturing companies take advantage of new technologies, such as the Internet of Things (IoT) and Industry 4.0, to improve connectivity and enable real-time access to information.
  3. Most QMS programs are managed electronically with tools ranging from Excel to purpose-built QMS tools. About half of the survey respondents indicate they use general-purpose tools and over 80 percent noted they are asked to “make do” with legacy QMS tools and solutions.
  4. Most days, 3 medical manufacturing companies receive a letter indicating their medical device or component did not meet the requisite QMS standards. It is crucial that OEMs understand the QMS requirements for their specific medical component in order to remain in compliance with FDA and other standards.

ProMed’s Commitment to Quality

At ProMed, quality is not just a department, it is a cultural commitment. We understand the importance of quality to your success. That is why quality is embraced every step of the way to create a product that will assure confidence in your products.

Partnering with an experienced injection molder like ProMed allows for the necessary production planning needed to meet all of the necessary regulatory, quality, and commercial standards. Our work force is highly specialized in the manufacturing and quality requirements of medical products, much of which go into the long-term implantable market space. Every employee at ProMed is trained with the idea that quality is their most important responsibility.

Our equipment utilizes 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!

We are an approved, certified supplier to many of the top medical device manufacturers in the world. All ProMed facilities go through routine audits by our ISO registrars and customers. Below is a sample of the standards we meet. Additionally, our products are wholly synthetic, not animal derived, and do not contain substances of very high concern or materials sourced from conflict regions.

  • ISO:13485 – 2016 certified
  • ISO:17025 certified
  • FDA 21 CFR 820, 210/211 and part 4 compliant

  • ISO Class 7 Clean Room
  • REACH and ROHS compliant

  • ISO:13485 – 2016 certified
  • ISO:17025 certified
  • FDA 21 CFR 820, 210/211 and part 4 compliant
  • ISO Class 7 Clean Room
  • REACH and ROHS compliant

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


liquid silicone rubber, medical manufacturing, LSR molding

The Future of Liquid Silicone Rubber in Medical Manufacturing

Medical manufacturing continues to face more challenging requirements for medical products as well as stringent regulations and end-user expectations for devices such as wearables. Manufacturers are tasked with meeting these demands while keeping costs low without sacrificing quality. One technology that manufacturers are turning to, and that stands out from the competition, is Liquid Silicone Rubber (LSR) molding. As demand continues to grow, the future of LSR in medical manufacturing looks very promising.

What is LSR?

Liquid Silicone Rubber (LSR) is a very-pure, platinum-cured elastomer. LSR starts out as a 2-part liquid that is heated in order to accelerate the reaction of the two parts to form solid rubber that can be injected into a mold cavity to manufacture a part. LSR has excellent properties, such as a low viscosity and low shrink rate, that make it a great choice for injection molding and the manufacturing of complex products and intricate parts. One of the advantages of LSR is that it cures faster than most other rubber materials; 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. LSR is a versatile rubber in the elastomer industry and has a wide range of end-uses including medical devices such as stents and catheters. Click here to learn why the medical industry uses silicones.

Benefits of LSR in Medical Manufacturing

In medical manufacturing, LSR has many attractive properties such as durability, low viscosity, chemical and temperature resistance, and flexibility, but 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 resistant 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. Additionally, demand continues to grow for wearable medical devices, leading to even higher LSR demand.

Medical manufacturing typically requires a higher level of cleanliness to avoid contamination during processing. In fact, many manufacturers, like ProMed, employ cleanrooms to minimize risk of contamination and achieve the necessary cleanliness during manufacturing. One of the benefits of LSR is that it can be injection molded, which is a highly automated process, further reducing the risk of contamination from operators, equipment, or the environment.

Have a medical manufacturing project that demands biocompatibility?
Contact the team at ProMed team to learn more about our broad range of LSR molding solutions.

Continued LSR Market Growth

The LSR market has experienced continuous growth and expansion in recent years, and this trend is projected to continue over the next 5-10 years. Some sources forecast the global LSR market will grow at a rate of 7.1% in terms of value, from USD 2.4 Billion in 2020 to USD 4.2 Billion by 2028. The healthcare sector is one of the primary drivers for LSR demand increases world-wide as medical manufacturing is experiencing significant growth.

The growth of LSR for the medical sector is attributed to a few key factors. First, due to its excellent biocompatibility, the demand for implantables continues to grow, driving the need for liquid silicone rubber. Second, there is growing demand for LSR in equipment and surgical tools necessary to treat the rising geriatric population. Lastly, LSR has hypo-allergenic characteristics that make it an excellent material for medical products that come in contact with human skin, such as wearables and medical products for babies.

For these reasons, the future of liquid silicone rubber in medical manufacturing is forecasted to be strong. It should be noted that, similar to most sectors, the COVID-19 pandemic has disrupted the global LSR supply chain. However, the supply chains are expected to fully recover and not impact the short- or long-term demand for liquid silicone rubber in medical manufacturing.

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 have multiple manufacturing sites, all are certified class 10,000 / ISO Class 7 cleanrooms.

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


5 Advantages of Additive Manufacturing

Many conventional manufacturing methods, such as CNC machining, use tools to cut and carve material into the desired shape and size. These traditional techniques are subtractive in nature since they start from a block of raw material, and material is removed as necessary to reach the final product. On the other hand, as the name implies, additive manufacturing technologies start from nothing and add layer by layer of material to create the final product. AM employs CAD software to control the deposit of material, layer upon the previous layer, to fabricate the desired 3-dimensional product. As the product cools, the layers are bonded together to form a strong, durable product. Additive manufacturing methods can be used with a range of raw materials including plastics, ceramics, and metals.

There are various AM processes on the market such as material extrusion, powder bed fusion, and jetting, but 3D printing is the most widely known method. In fact, the terms additive manufacturing and 3D printing are often used interchangeably but there is a key distinction: 3D printing is one of several fabrication technologies under the umbrella of additive manufacturing.

AM is part of the digitalization of manufacturing that is often referred to as Industry 4.0. AM technologies have advanced significantly in recent years and are transforming the way many manufacturers operate. AM, specifically 3D printing, is one of the fastest growing industries in the U.S. today and conditions are ripe for innovation. The true potential for AM and 3D printing lies in the new opportunities for creativity that it provides – and not what forms of manufacturing it will replace.

5 Advantages of Additive Manufacturing

Additive manufacturing offers many advantages over traditional manufacturing techniques, and many manufacturers are turning to this method to reap the benefits. Below are 5 key advantages of additive manufacturing.

  1. Faster Cycle Times: additive manufacturing methods are known for their speed. 3D printing only needs a new CAD input in order to manufacture a new product and does not require retooling or machine changes – resulting in significant time savings. Additionally, 3D printed parts are one single piece and do not require secondary operations, further reducing lead times. For these reasons, 3D printing is a cost-effective option that allows designers to rapidly prototype and test new ideas.
  2. Less Waste: traditional, subtractive manufacturing naturally generates waste since manufacturers start with a large block of raw material and remove material to reach the desired shape and size. For example, during CNC machining the metal waste must be collected, cleaned and recycled, costing OEMs both time and money. Conversely, additive manufacturing methods, such as 3D printing, generate significantly less waste than traditional manufacturing, and in some cases, waste can be entirely eliminated.
  3. More Nimble Production: traditional manufacturing, such as CNC machining or injection molding, requires tooling that is difficult to modify once production is initiated. However, additive manufacturing is able to innovate and tweak designs during the production phase by simply changing the CAD input to accommodate customer feedback or other design improvements – with no tooling changes required. 3D printing also saves OEMs time and money as tooling is typically time-consuming and costly to fabricate.
  4. More Design Flexibility: AM products are 100% customizable. Additive manufacturing provides designers with more creativity and flexibility in part designs in order to experiment with different shapes and weights to address market demands. For example, AM is proving itself an excellent solution for parts used in tight spaces such as airplane cabins that require unique shapes and lighter weights. Additionally, 3D printing is becoming the go-to fabrication method for prosthetics due to its ease of customization and ability to create intricate and complex parts.
  5. Optimized Inventory: additive manufacturing techniques, like 3D printing, allow manufacturers to fabricate parts on-demand rather than stock piling spares in a warehouse – resulting in lower storage, inventory, and transportation costs.

About ProMed

For over 30 years, ProMed has specialized in producing small, intricately designed silicone and plastic components, combined with value-added services and subassembly capabilities to support both life-saving and life enhancing devices. In alignment with these focused services, ProMed Pharma provides complete manufacturing, assembly, and testing support for drug delivery and combination devices.

We work together with our customers from concept to completion by providing design for manufacturability input, material selection, tooling/fixturing, process development, manufacturing and value-added services that result in cost-effective solutions and superior quality.

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