Contract Sterilization: An Overview
When a manufacturer cannot sterilize its products in-house, they often turn to a contract sterilizer. Contract sterilizers provide sterilization services for regulated products, including medical devices, drugs, and biologics.
The most common sterilization methods used by contract sterilizers are:
- Steam Sterilization
- Gravity autoclave
- Pre-vac autoclave
- Gas Sterilization
- Ethylene oxide (EtO) sterilization
- Chlorine dioxide sterilization
- Radiation Sterilization
Through a contractual agreement, both the manufacturer and the contract sterilizer define their respective roles and responsibilities to ensure compliance with current Good Manufacturing Practices (CGMP). This ensures the sterilization process meets regulatory standards.
Roles and Responsibilities
The responsibilities of the manufacturer and the contract sterilizer are clearly outlined in their agreement. Both parties must ensure their processes conform to applicable CGMP regulations, such as:
- 21 CFR Parts 210 and 211 for drugs.
- 21 CFR Part 820 for medical devices.
Manufacturer’s Responsibilities:
- Ensure the finished product meets sterility expectations.
- Confirm that products are processed under CGMP controls.
- Validate the sterilization process to achieve a sterility assurance level (SAL) of 10⁻⁶, meaning there is less than a one in a million chance of a viable microorganism surviving on a given sterilized product.
Contract Sterilizer’s Responsibilities:
- Maintain cGMP controls such as equipment qualification and written procedures.
- Implement and consistently maintain sterilization processes to meet regulatory expectations.
Both parties share the responsibility of ensuring the contract sterilization procedures align with regulatory requirements.
Sterilization Process Validation
How does a company ensure the sterilization process is effective and consistent? The process must undergo validation in accordance with 21 CFR 211.113(b) and 21 CFR 820.75. Validation can be performed:
- In-house by the manufacturer.
- By a third-party laboratory like Microchem, offering an unbiased assessment.
The purpose of validation is to confirm that the sterilization process consistently achieves expected results. For sterilization, this typically means achieving a sterility assurance level (SAL) of 10⁻⁶. Validation ensures regulatory expectations, such as those set by the USP or EPA, are met. Depending on the sterilization process, bioburden testing, sterility testing, or both may be conducted.
Regulatory Oversight and Compliance
The FDA considers the manufacturer primarily responsible for ensuring CGMP compliance. However, both the manufacturer and the contract sterilizer are accountable for the procedures performed by the sterilizer. If any significant compliance issues arise, the appropriate FDA center is notified.
Potential Consequences:
- Temporary closure of a contract sterilizer due to significant findings may lead to shortages of critical medical devices or drugs.
- The FDA monitors these situations closely to redirect products and minimize supply disruptions.
Why Contract Sterilization Matters
Contract sterilization ensures that regulated products meet stringent sterility standards, even when manufacturers lack in-house capabilities. By collaborating with contract sterilizers, manufacturers can rely on expert sterilization methods while focusing on their core operations. The partnership ensures compliance with regulatory standards, safeguarding public health and product availability.
Does Microchem Laboratory Provide Contract Sterilization?
Microchem Laboratory does not provide contract sterilization, but offers a complete range of testing services to support companies making sterile products. We also work closely with several contract sterilizers and are glad to make introductions and work to ensure your project is handled smoothly. Microchem’s services include sterility assurance, bioburden, and endotoxin testing, as well as the conduct of a host of validation studies. Contact the lab for a assistance.