OUR SERVICES

Validations

Design Qualification DQ

Analysis of the documentation for the design of installation of relevant machinery to verify

the adjustments to the user’s requirements.

Installation Qualification IQ

Creation of IQ report for installation, as Air Treatment Systems, Water Obtaining Systems

or machinery with relevant impact to the product quality, as autoclaves, Oven, lyophilizer,

etc.

Operational Qualification OQ

• Heat distribution studies in autoclaves, dry heat oven, lyophilizer, Oven, refrigerator room, climatic room, etc.

• CParticle count, DOP test, air speed, differential pressures in manufacturing clean areas at rest

•  Environmental Controls of warehouses (with measure of average kinetic Tª)

• OQ test for water treatment Systems and other relevant machineries.

Process Validation PQ

• Heat penetration studies in autoclaves, dry heat oven, etc.

•  Particle count, recovery test, etc. in manufacturing clean areas in operation.

• Validation of other manufacturing process, such as weighing systems, water obtaining systems, aseptic filling, blending, granulation, compression, packaging lines.

• Validation of warehouse IT Systems, weighing management systems, etc.