The sterilization process is the most important step during product manufacturing. Regulatory agencies highly scrutinize this process for the right reason, which is patients’ safety. This industry uses many different kinds of sterilization methodologies from simple steam to complex chemical treatments. These methodologies involve complex interaction of products with different chemicals, radiation, gases, etc. Some examples are:
- Liquid chemical sterilization: Glutaraldehyde or Formaldehyde, or combination chemicals
- Steam sterilization,
- Ethylene Oxide sterilization [EO or ETO],
- Gamma sterilization,
- e-beam sterilization
Development of sterilization strategies and implementation
- We will work with your company to identify the suitable sterilization method for your product and implement the same as per ISO 11137-1, -2, -3, ISO -11135, ISO -14160. We will design inactivation kinetics, sterilization cycles, optimize processes and parameters.
Qualification and Validation
- We will conduct sterilization qualification and validation.
- We will source and manage the contract laboratories, write protocols, coordinate the validations, conduct technical review of the data, and write reports.
- Coordinate and conduct annual revalidations for sterilizations and quarterly dose audits for gamma sterilization
IQ / PQ / OQ
We will conduct qualification of sterilizers:
- Installation Qualification (IQ)
- Performance Qualification (PQ) and
- Operational Qualification (OQ)
- We will work with your company on issues related to sterilization non-conformances, sample disposition, false positives, etc.
Corrective and preventive actions
- We will conduct root cause analysis of sterilization related issues and implement corrective and preventive actions
Preparation of SOP
- We will prepare SOP for sterilization qualification validations, annual revalidations etc.
- We will develop procedures for auditing contract sterilizers, conduct audits and generate reports
- We will conduct gap assessments on current sterilization process and will bring it up to compliance.