Contamination control is a critical aspect of drug development. Even small amounts of contaminants can have severe consequences for the safety and efficacy of drugs. Therefore, it is essential to implement and maintain effective contamination control measures at all stages of the drug development process, from early research and development to manufacturing and packaging.
In this blog, first, we explore different sources of contamination and their consequences. We then look at what contamination control measures your company can take and why air filtration should be a vital consideration in this process.
Sources of Contamination
There are many potential sources of contamination in drug development. These can affect the drugs at any stage of development, from the raw materials to the finished product.
Three of the main sources of contamination are:
- Microorganisms: Bacteria, viruses, and fungi
- Particulate matter: Dust, dirt, and other particles
- Chemicals: Chemical moisture, gas, or molecules from cleaning agents, disinfectants, or other sources
There are also endotoxins, which are pyrogenic substances produced by gram-negative bacteria. If drugs or vaccines are manufactured using these types of bacteria, they are at a high risk of being contaminated with endotoxin.
Consequences of Contamination
If your drugs become contaminated at any point during the development process, this contamination could lead to serious consequences. As well as impacting the safety and efficacy of the drugs, there could be significant financial implications. For example, contaminated drugs can:
- Cause infections and other adverse reactions in patients.
- Reduce the efficacy of drugs.
- Lead to product recalls and other significant financial setbacks.
- Damage your reputation and relationships with your customers.
One such case study on the impact of drug contamination is that of the drug manufacturer Genzyme (now part of Sanofi Genzyme). It had to pause the manufacture of the drugs Fabrazyme and Cerezyme when a virus was found to have contaminated a bioreactor. With these drugs used by 8,000 patients, the estimated cost of this interruption in production was up to $300m.
Another example is in 2011 when Baxter Healthcare was under investigation due to endotoxins being discovered in its dialysis solutions. These harmful substances may have led to adverse reactions in patients on kidney dialysis.
With drug contamination resulting in such severe impacts, rigorous containment systems are vital.
Contamination Control Measures
There are several key areas where control measures must be implemented during the drug development process to avoid contamination. These include:
- Facility design and engineering: Your drug manufacturing facilities should be designed and engineered to minimise the risk of contamination. This process includes using cleanroom technology, air filtration systems, and other engineering controls.
- Process control: Good manufacturing practices (GMPs) should be followed at all stages of the drug development process to minimise the risk of contamination. These practices include using standard operating procedures, training personnel, and conducting quality control checks.
- Environmental monitoring: Environmental monitoring should be employed to detect and quantify contaminants in the air, water, and other surfaces in your drug manufacturing facilities. This information can guide you in taking corrective action and preventing contamination.
The Role of Indoor Air Filters in Contamination Control
Air filters are crucial in drug contamination control within pharmaceutical manufacturing facilities. These filters are designed to remove airborne contaminants, ensuring the purity of the produced pharmaceutical products.
High-efficiency particulate air (HEPA) filters are commonly used in cleanrooms and controlled environments, such as drug manufacturing facilities. Designed to ensure ultra-clean air and avoid the damaging impact of contamination, they can remove up to 99.97% of all particles from the air that are 0.3 microns or larger. Testing and monitoring an installed HEPA filter is critical to ensure its continued efficacy in delivering the approved air quality levels.
Contamination control is essential for the safety and efficacy of drugs, and high-quality air filtration plays a vital role. By preventing contaminants from entering critical production areas, air filters safeguard drug production processes, helping your pharmaceutical company meet regulatory standards and produce safe, effective medications for patients worldwide.
To learn more about how Filtrex supports the air quality requirements of the pharmaceutical industry, please get in touch with our team.