Stericonsultorio’s services covers the area of sterilization and microbiology consulting. Services provided include consulting such as:
- validation and revalidation sterilization activities according to ethylene oxide and radiation sterilization standards
- selection of sterilization method
- product design for sterilization
- adoption of products into products families for sterilization, EtO residuals and bioburden
- new products implementation to validated cycles
- annual sterilization review, annual bioburden review and requalification
- development and validation of test methods for bioburden, sterility, EtO residuals
- dose audits and dose mapping for radiation sterilization
- supplier audits of sterilization service providers
- microbiological analysis of product, raw materials and environment; initial product contamination; monitor the production environment (clean room)
- cleanrooms and associated controlled environments; classification of air cleanliness by particle concentration
- CAPA, NC, OOS process; root cause analysis
- creation of the quality documentation (write and review) related to microbiology and sterilization section
- sterilization risk assessment
- microbiological risk assessment
- QA, R&D project supports
- response to questions and observations from regulatory units
- implementing solutions for issues in the sterilization and microbiology section