Ensuring the Pinnacle of Sterility Through Rigorous Autoclave Validation
At Wickham Micro, we understand the critical importance of maintaining the highest standards of sterilisation in pharmaceutical and medical device manufacturing. To achieve this, we offer comprehensive support for your Autoclave Qualification that enable you to validate your autoclaves with precision and confidence.
Autoclaves are the cornerstone of sterilisation, and demand meticulous validation to ensure their effectiveness.
Tailored Support for Your Autoclave Validation Needs
At Wickham Micro, we recognize that every client's requirements are unique. Therefore, our Autoclave Qualification services offer flexibility, catering to your specific needs:
- Consultation: We provide expert advice and guidance to help you understand the validation process.
- Supply of Necessary Resources: From biological indicators to testing equipment, we ensure you have everything required for validation.
- Comprehensive Validation Services: Our team of experts can lead the validation process, performing all necessary tests and analyses.
Frequency of Autoclave Validation
Autoclave validation is an ongoing commitment to quality. It is typically conducted on an annual basis for each piece of equipment. This ensures that your sterilization processes remain effective and compliant with industry standards.
The Autocalve Validation Process
An Autoclave Qualification process involves:
- Biological Indicator Qualification: We can provide enumeration and identification on your biological indicators to ensure that they meet their claims. For Self-contained Biological Indicators (SCBIs) we can also perform growth promotion on the media to ensure that it is fit for purpose.
- Cycle Run: The autoclave is run using the standard sterilization cycle and along with thermocouples placed throughout the chamber, BIs are also placed within the chamber in appropriate locations.
- BIs in Test Broth: After the cycle, the BIs are added to appropriate growth media and incubated and monitored for any turbidity or a colour change over a defined period, typically 7 days. It is critical that the BIs are placed into the media as quickly as possible after completion of the cycle.
- Positive Controls: Unexposed BIs are run concurrently to show that the BIs are suitable for purpose during storage, use and transportation .
- Specific Autoclave Cycles: Each different autoclave cycle and load requires individual qualification.
Beyond Autoclave Qualification
our unwavering commitment to GMP and GLP, coupled with our highly trained staff, is the cornerstone of our high-quality services. We excel in ensuring the reliability of your validation processes by assisting in Biological Indicator qualification.
We can also support in a similar way your Depyrogenation Ovens Validation and Isolator Validation.
Contact Wickham Micro
For trusted support for Autoclave Qualification services that uphold the highest industry standards, contact Wickham Micro today. We are committed to helping you ensure the sterilisation of your products is both effective and compliant.
