Pharmaceutical & Biotech Industry
Sun Sterifaab delivers GMP-grade sterilization solutions for pharma and biotech industries, ensuring product purity and regulatory compliance. From autoclaves to ETOs, we support cleanroom safety with validated, 21 CFR Part 11-compliant systems and full documentation.
About the Industry:
This industry handles life-saving products, such as injectables, vaccines, biologics, and diagnostics. Even the smallest microbial presence can render a drug ineffective or harmful. Therefore, controlled environments and validated sterilization protocols are essential.
Products That Require Sterilization:
- Glass vials, ampoules, rubber stoppers
- Stainless steel utensils and filtration equipment
- Bioreactor components
- Filling and packaging materials
- Ready-to-fill syringes and cartridges
Importance of Sterilization:
- Eliminates bioburden for parenteral drugs
- Ensures stability, purity, and shelf-life
- Minimizes batch rejection and regulatory non-compliance
- Prevents contamination in cleanroom and aseptic environments
How Sun Sterifaab Supports the Industry:
- Custom-built GMP-grade Autoclaves and Retort Sterilizers
- High-capacity ETO sterilizers with inbuilt aeration
- Full compliance with 21 CFR Part 11 for data logging and traceability
- Annual calibration, revalidation, and performance audits
- Full documentation support: IQ/OQ/PQ protocols, training & validation.
- In-house technical and validation team to support factory and site acceptance tests
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