Quality Systems
At Microsize, we operate our facilities to the highest levels of regulatory compliance including US FDA Title 21 CFR Parts 210/211 GMPs. Our facilities, equipment and cleaning protocols are designed to ensure zero cross contamination and provide optimal containment for APIs, HPAPIs, and Excipient processing. Microsize has undergone numerous successful FDA audits over the past three decades, and we host dozens of customer audits each year.
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We are proud of our strong Quality position. Here’s why:
- Immaculate Processing – Our best in class approach to cleanliness and prevention of cross contamination is immediately evident to touring clients
- Isolation/Containment Specialists – We are Experts in safe handling of APIs and HPAPIs including high containment systems in both hard wall and single-use flex wall containment approaches
- Stellar FDA Inspection History – Dozen+ successful FDA inspections over the past 25+ years supporting developmental and commercial API and Excipients
- Validated Cleaning Protocols & Verification – 100% Equipment swabs and product specific testing after each API cleaning event provides the highest level of assurance between runs on an validated cleaning approach
- Digital QMS Solutions – For efficient and compliant management of document control, CAPA, personnel training, change management and inventory tracking with the migration to electronic batch records underway
Facility Design Attributes
- Independent, HEPA filtered processing suites qualified to ISO 8 level particulate levels
- Pressurized Airlocks and high speed (quick close) rollup doors
- Filtered bag house collection approach for better contained processing
- Negative pressure pickups at charging and packaging areas
- Vigilant operator protocols to prevent dust propagation during charging, sampling and packaging
- Easy clean facility surfaces and equipment designs
- Routine particulate measuring program