Pharmaceutical

BRIZIO BASI produces lyophilisers and pumping groups; it also provides certification and maintenance of plants (also from other manufacturers).

Pharmaceutical Sector Validations. More and more what differentiates production in a globalized world is quality. For this reason it must be demonstrated that the production process is correct and documented. This aspect is proven through Certifications and Validations. We create and compile “IQ” Installation Qualification protocols, “OQ” Operational Qualification, “PQ” Performance Qualification and “CV” Cleaning Validation.

• Equipment Validation Protocols (IQ – OQ – PQ)
• Test execution validation for “Cold-hot distribution mapping on plates, autoclaves, condensers”.
• Vacuum, pressure and temperature probes certification, at Brizio Basi or customer, with Accredia certified comparator.
• Certification of acquisition systems (recorders or computers), with comparison of certified measuring instruments.
• FGAS regulation refrigeration unit certification.
• Leak test with helium gas – Elium Leak Test.

• Sound Pressure Measurement.
• Measurement of electrical leakage.
• Measurement by comparison with certified devices.
• Measurements and calibration of environmental and plant sensors

Maintenance on: Freeze-dryers, Autoclaves, Condensers, Refrigeration units, Vacuum pumping groups, Oil pumping units, Hydraulic units, Safety systems for detecting toxic or asphyxiating gases, Sterilization plants.