There are risks in the machining plastics in the medical and pharmaceutical industries. Manufacturers of medical equipment and pharmaceutical packaging, as well as their customers, need to ensure that there is no chance that certain defects or omissions will cause patients to experience bad experiences. Therefore, companies that supply parts must also remain vigilant to ensure that the measures they take will not compromise the performance or safety of the final product.
Plastics used in health care have important functions, such as rapid diagnosis, minimally invasive surgery, self-administration and reducing the spread of bacteria, as well as protecting drugs from moisture and oxygen. These materials must provide consistent properties, including resistance to sterilization, chemicals and lipids. They usually must also meet biocompatibility and toxicity standards, in which even small changes in the composition of the Plastic used may affect the acceptability of the final device. For these reasons, regulatory agencies such as the US Food and Drug Administration and relevant European agencies require plastics to have “good properties”, and provide detailed information about material composition and formulation, manufacturing processes, and extensive support for physical and mechanical properties. data.
Ultimately, the responsibility for assembling all these documents lies with the company that puts the device on the market, as it has become part of the data package required to approve the use of the device. However, as regulators are more and more carefully reviewing the risks of changes in the entire supply chain, even if OEM customers specify, processors (tier 1 and tier 2 and tier 3 suppliers) pay attention to the plastic materials they purchase The responsibility is also growing.
From the early stages of the design process, all of this speaks out for collaboration between all parties in the supply chain. When all goes well and goes according to plan, bringing FDA-approved medical devices to the market is very complicated. Plastic parts and the ingredients contained in them may represent the low cost of each device, but in the end, they play a vital role in the quality and reliability of the final device, so if there are plastic parts, it may have a huge cost Impact is a problem.
A plastic processor who understands the problem and understands its role in the risk management process can be a great asset for a medical or pharmaceutical manufacturer. Knowing the importance of change control, maintaining clear communication channels and investing in Good Manufacturing Practices (GMP) can greatly reduce risks in all relevant aspects and make such processors a valuable partner.
What is a medical grade polymer?
Except for very few cases, there is no real “medical grade” polymer. In fact, almost all resins can be used in medical applications, as long as it has “good properties” and the consistency has been properly controlled. This means that the potential risks of the material have been assessed and are acceptable.
Once these materials are properly recorded, medical device manufacturers can use them in their designs and products while meeting design and application requirements. However, this document was submitted at a point in time and is specific to materials and formulas. During the entire life cycle of a product, and at any time in the sometimes highly complex supply chain, any material or formulation changes may invalidate previous approvals.
It is at this point that “change control” becomes an important and difficult challenge. Any changes anywhere in the supply chain (production locations, processes, specifications, quality systems, and even minor components) may affect the characteristics of materials.
Plastic parts and the ingredients contained in them are critical to the quality and reliability of the final equipment.
In terms of its responsibilities to the supply chain, the FDA has become increasingly strict with medical device and drug manufacturers. In the past, it was sufficient for equipment manufacturers to monitor their direct Tier 1 suppliers. In turn, they are responsible for ensuring that their sub-suppliers can meet basic quality requirements. All the equipment manufacturer needs to do is to confirm that the appropriate audits have been completed and documents have been prepared. Everything has changed. Now, the FDA says that medical device companies or pharmaceutical companies must also be accountable to Tier 2 and Tier 3 suppliers. They must ensure that every link in the supply chain meets the overall GMP requirements for change management.
This is why ISO 13485 certification is becoming more and more important, especially because the FDA proposes to coordinate the framework adjustment system of the ISO standard. ISO 13485-2016 is a standard management organization involved in the design, production, installation and maintenance of medical equipment. If upstream suppliers (such as plastic processors) are also certified to the standard, they can provide customers with assurance that they have invested in and understand the core medical device risk management principles of the standard. In addition, quality control and testing procedures have been applied to the raw materials used in the components they provide, and there are documents certifying the materials.
Likewise, just because the material has been used in the previous generation of equipment does not mean that the material can also be used for similar applications in the future. Since the original design, it is extremely unlikely that these materials will truly remain the same. The FDA has issued several guidelines on this topic.
What should be paid attention to in production?
Any material supplier seriously serving the medical/pharmaceutical market will have a thorough understanding of end-use application requirements, medical device regulations that OEMs must meet, risk management practices, and they will develop change control measures. Usually, this involves enhanced GMP and possibly high-level quality standards (such as ISO 13485-2016) certification.
Certain material suppliers have taken additional steps to produce combinations of materials specifically for healthcare applications. For example, Borealis produces a special series of polyolefins called Bormed, while Lyondell Basell produces similar polyolefins under the Purell brand. Others follow a similar path, so a fairly wide range of polymers are available.
As far as polymer production is concerned, although the grades designated for healthcare are produced in the same reactor, they are manufactured under stricter quality control and promised to change notice, long-term supply, and according to selected Pre-tests conducted by applicable health care regulations. When using pigments or additives to modify polymers, the range of parameters and ingredients to be controlled is much larger. Avient’s Mevopur product line covers final compounds as well as color masterbatches and additive masterbatch concentrates, providing guarantees similar to those of the aforementioned polymer manufacturers. (Note: Avient is a new company formed by PolyOne’s acquisition of Clariant masterbatches.)
Efforts are being made to better define what is “medical grade” plastic.
However, these types of procedures and commitments are still exceptions. Not all material production processes and specifications are designed with change control in mind. For economic reasons, they often frequently replace primary and secondary components, such as pigments, stabilizers, and lubricants. Therefore, there is an increasing need for careful procurement procedures at each level of the supply chain to ensure that the materials have the necessary guarantees and control measures have been established.
Efforts are currently being made to better define what is “medical grade” plastic. The German Association of Engineers VDI has been studying such a standard and recently published it as VDI: 2017 in German and English. However, it only covers polymers, and since polymers are often modified downstream (for example, through masterbatch coloring or compounding), and these modifications increase risk, the scope may be too narrow.
MedPharmPlast Europe has a wide range of members and is one of the few trade associations that are truly vertically organized, covering the entire supply chain of the medical and pharmaceutical markets. It is also developing standards for medical-grade materials. It is expected that it will contain the elements of the VDI standard and other elements that are modified downstream through mixing and enrichment.
What about colorants and additives?
Minor components such as colorants and additives can be pre-mixed into the polymer or introduced in the form of a masterbatch during the molding or extrusion process. Although the polymer to be used may be decided very carefully, these minor components can easily be overlooked, which can cause problems.
In fact, the FDA had previously recommended treating colorants and additives as “contaminants” in polymers, so they need to be controlled as strictly as the polymer itself. What makes these situations worse is the fact that decisions about these materials are usually left to the processor. The equipment OEM can specify the main material, and then simply specify the color standard (such as Pantone, RAL), and then the processor provides the color standard. Think that the molding machine or extruder is “proven” and may even choose colorants or additives that have been used in similar applications in the past. However, this will not pass the FDA. Their assumption is that something in the material will change over time, so these minor components need to be re-evaluated and fully recorded.
The regulatory compliance and quality of medical devices or pharmaceutical packaging are only as good as their weakest link, which is why it is necessary to ensure that everything remains the same. Generally, pigment and additive suppliers do not issue notifications of changes. Avient’s Mevopur team has established a “fingerprint” of the incoming material to detect any changes.
This composite production line in Lewiston, Michigan, USA is one of Avient’s three global production facilities for medical-grade masterbatches and compounds in Mevopur, and is isolated to reduce pollution.
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