Pharmaceutical Industry

Contamination control strategy for sterile medical products

Monday, 29.01.2024. - 10:00

If you work in the field of pharmaceuticals or are a manufacturer of medical devices, contamination is probably one of your biggest concerns. When we talk about contamination, a stable and well-developed contamination control strategy (CCS) plays a key role here. In simple terms, CCS means the steps you need to take to ensure sterility in your pharmaceutical manufacturing. The new revision of the EU GMP standard from 2022 is an attractive topic that has put the contamination control strategy for the production of sterile medical products in the spotlight. Read below why it is crucial to have a well-developed contamination control strategy and what exactly these regulations are about.

Why is the implementation of a contamination control strategy important in GMP production?

Imagine that you are producing the next type of drug that will be a real innovation in the market. You have your formulation, your process, and you're ready to offer this great product to patients - but what if there's microbial contamination in your manufacturing environment? What if your equipment is not properly cleaned? You can probably guess the fatal consequences of this story.

Contamination in the life cycle of the production of drugs or medical products (e.g medical devices) can have catastrophic outcomes. It can threaten product quality, patient safety and ultimately your company's reputation - that's why the importance of an elaborate contamination control strategy is extremely important. Your plan is to ensure that your products are safe and free of contamination.

What are the potential contaminants in sterile production?

To effectively fight contamination, it is essential to familiarize yourself with the types of contamination. Contamination can come from a variety of sources, and for sterile products, the main types of contamination include:

  • Microbial contamination - includes bacteria, viruses, fungi and other microorganisms. These invisible contaminants can come from the environment, personnel or raw materials and can potentially ruin your product.
  • Particulate contamination - this refers to physical particles such as dust, fibers or metal shavings that can contaminate the product. Imagine finding a piece of metal in a medicine bottle!
  • Chemical contamination - contaminants that can be extracted and washed away are a problem for both sterile and non-sterile products. This occurs when unwanted chemicals are released into a product, either in the manufacturing process or through cross-contamination with other products.

Develop a solid contamination control strategy

Creating a contamination control strategy is a proactive approach - by anticipating all risks in advance, you can put all the necessary controls in place to prevent contamination.

Here's how companies usually do it:

  1. Risk assessment: This is the first step in building your own strategy. It includes the identification of potential sources of contamination and risk assessment from them.
  2. Preventive measures: Based on risk assessment, companies implement measures to prevent contamination. This may include procedures such as proper sanitation practices, air filtration systems, and staff training.
  3. Monitoring: Regular monitoring is essential to ensure the effectiveness of preventive measures. This may include environmental monitoring, product testing and audits.
  4. Corrective actions: If contamination is detected, companies must take immediate corrective actions. This could mean recalling contaminated products, investigating the source of the contamination and implementing measures to prevent recurrence.

Meeting standards: What is the role of regulatory bodies?

Both the FDA (Food and Drug Administration) and the EMA (European Medicines Agency) have strict requirements for CCS.

The FDA requires companies to have a written CCS that outlines their approach to preventing, detecting, and correcting contamination. They are asking for a detailed description of their sanitation procedures, an environmental monitoring program and a corrective action plan.

Similarly, EMA requires companies to have a robust CCS in place. They also emphasize the importance of a risk-based approach, where companies focus their efforts on areas of greatest risk.

EU GMP Annex 1 for sterile medical products

So what does the new EU GMP Annex 1 revision say? This update of EU GMP Annex 1 is a major revision of the guidelines for the manufacture of sterile medical devices. It basically provides a more holistic and risk-based approach to ensure quality and safety. One of the key aspects of the update is the requirement for a comprehensive CCS that covers all the bases, such as:

  • Avoiding cross-contamination
  • Ensuring sterility
  • Control of biological contaminants (eg bioburden, endotoxins, prions)
  • Control of foreign particles (inanimate, visible/visible, internal/external)

There is also more detailed guidance on how to implement CCS in various areas, such as environmental monitoring, cleanroom design and classification, and rapid microbial methods.

Reliable Sartorius solutions for contamination control strategy

A good contamination control plan includes proven solutions from trusted industry suppliers, such as our Sartorius solutions.

To comply with efficient CCS, MD8 Airscan and gelatin filters enable truly continuous non-interventional air monitoring (as required by EU GMP Annex 1) and Sterisart® containers enable aseptic sampling and supplementation of your sterility testing.

For bioburden testing, the Microsart® @filter and Microsart® @media system are designed to prevent secondary infection during the critical membrane transfer step - which you can do completely touch-free!

Rapid microbiological testing products are also important; they give you fast data so you can minimize the potential impact on production lines. Sartorius' Microsart® qPCR kits can detect mycoplasma, bacteria and fungi in 3 hours – now that's fast!

The article was taken and translated from the official Sartorius site.