Life science products are unique because they interact directly with patients’ body functions. Products like pace-makers and parenteral (e.g., injected) drugs are directly incorporated into patients’ hearts and bloodstreams. This direct interaction is what makes life science products effective. But, it is a double-edged sword, since it creates a serious risk of harming patients if the products are not properly manufactured.
Microbiologic contamination is an essential aspect that must be controlled during manufacturing. A robust sterilization strategy must be developed for the manufacturing process. This can be very complex task; many factors must be balanced to find an optimum strategy. Some factors to consider are: organisms of concern, destructive effects of sterilization on the final product, sterilization cycle time, utilities requirements, and regulatory compliance.
Typical sterilization processes are:
- Sterile Filtration
- Autoclave or Dry Heat Ovens
- Radiation Sterilization (e.g., Gamma Irradiation)
- Chemical Sterilization (e.g., Ethylene Oxide or “ETO”)
Kymanox has the expertise to help with all parts of the sterilization lifecycle, from initial sterilization method choice and regulatory strategy to equipment sizing, design, start-up, and validation.
Specifically, autoclaves are often at the heart of Pharma manufacturing facilities. Autoclaves use moist heat to sterilize a wide range of equipment, glassware, products, utensils, etc. Autoclaves are one of the most well-defined and easiest to control methods of sterilization. If the materials being sterilized can withstand the pressure, temperature, and moisture, then autoclaves are typically the most economical option for sterilization. Kymanox has extensive experience with autoclaves and can assist with everything from microbiological principles, equipment sizing, start-up, and load development to engineering Clean Utilities (e.g., Clean Steam), validation, and temperature mapping.