Manufacturing Validation
Your facility is only as functional as your equipment. ANSA understands how much is riding on the fidelity and compliance of your manufacturing tools.
We can match
your pace.
We support your facility in any stage of growth to ensure that your equipment stays in compliance with the highest standards.
Get a partner who can match your pace. Our team has the experience to hit the ground running and help you innovate safely and quickly.
Compliance Experts + Industry Experts
ANSA’s validation services stand above competitors’ because our expertise extends our capabilities to manufacturing. We offer a full-service experience that includes a mastery of manufacturing software and instruments, so you can focus on growth.
Types of Facilities We Validate
From Temperature Mapping to Filling Line qualifications, our seasoned experts bring compliance experience in pharmaceutical manufacturing from many disciplines, including:
- Manufacturing Suites
- Cleanrooms / Fill Lines
- Gene Therapy Facilities
- Vaccination Facilities
- Small Molecule Facilities
- Environmental Monitoring
- …And More
Validation for Manufacturing Instruments You Count On
Our team has direct experience with the manufacturing validation process for the laboratory instruments you rely on most:
- Controlled Temperature Units (CTU)
- Cold Rooms
- Freezers 2-5C, -40C, -50C, -70C and -150C
- Refrigerators
- Incubators
- Kaye Validator Experience (2000 and AVS)
- Stand-alone Temperature and Humidity Loggers
- Fume Hoods
- Bio-safety Cabinets
- Fermentors
- Viable and Non-viable Particle Counters
- Bio-reactors
- Tube Sealers
- Filter Integrity Testers
- Centrifuges
- Chromatography Skids
- Clean-in-Place (CIP) and Sterilization-in-Place (SIP) Cycles
- Riboflavin Testing / Sprayball Testing
- Autoclaves
- Aseptic Filling Lines
- Floor Balances
- Bio Controller
- Floor Centrifuges
- Fill/Finish Isolator
- Rocker Systems
- Microfluidizers
- Utilities, Including CO2 and Process Air Distribution Systems
Get Support for IQ, OQ, and PQ
At ANSA, we are partners throughout the validation lifecycle. No matter what the future holds, we are prepared to keep your facility on the cutting edge and in compliance with all relevant regulatory agencies.