Key Suppliers and Service Providers in Gujarat

Suppliers in Gujarat, concentrated primarily in Ahmedabad and Vadodara, typically offer automated integrity testers from major international brands:

• Global Brands Represented: Authorized dealers supply instruments from market leaders like Sartorius (Sartocheck series), Merck Millipore (Integritest series), and Porelab Scientific Private Limited (a Vadodara-based manufacturer offering their own M19 Filter Integrity Analyzer and testing services).
• Local Distributors: Companies like Protech AIR Systems Pvt Ltd (Ahmedabad), Hexa Pharmachem (Ahmedabad), Shreedhar Instruments (Ahmedabad), and Optima Instruments (Vadodara) are key contacts for purchasing, service, and validation.
• Validation Services: Many local firms, such as Akshar Validation and Validair Engineers (Ahmedabad), also offer comprehensive filter integrity testing services for both HEPA and process filters, using certified equipment.

Why Automated Integrity Testers are Crucial

Modern automated integrity testers supplied in Gujarat provide critical features to ensure high standards and compliance:

• Non-Destructive Testing: They perform tests (Bubble Point, Diffusion, Water Intrusion) that correlate directly to bacterial retention tests without destroying the filter.
• Data Integrity: They come equipped with software solutions compliant with 21 CFR Part 11, including audit trails and electronic signature capabilities.
• Validation Support: Suppliers provide necessary IQ/OQ/PQ validation protocols to qualify the instrument for use in a GMP environment.
• Eliminating Subjectivity: Automated pressure control and reading eliminate operator error inherent in manual bubble point observation.

The Bubble Point Test is the pressure at which a continuous stream of gas bubbles first appears from a wetted filter, indicating the pressure required to force liquid out of the largest pores. This pressure is then correlated to the microbial retention capability of the filter.