Clean room, HVAC, water system, CDA -compressed air and N2-nitrogen systems.

API manufacturing equipment‘s like Reactors, distillations units, filtration units, blenders, dryers, milling.

Sterile Injectable fill finish equipment‘s for Vial/Syringe/Cartridge products including Lyophilization

Isolator, RABS and their decontamination technologies like VHP/EtO.

Oral formulation/Vaccine/Cosmetic/biotechnology/biosimilar/CRO/packaging materials manufacturing equipment

URS - User Requirement Specification/FRS - Functional Requirement Specification/SDS - software design specification

IA - Impact Assessment (for Systems/Equipment/Component Criticality) & RA - Risk Assessment

DQ - Design qualification and design reviews

FAT (Factory acceptance tests) / SAT (Site Acceptance Test) / Commissioning documents

IQ - Installation qualification / OQ - Operational qualification / SOP - Standard operating procedures

PQ - Performance qualification / Summary Report / RQ - Re-qualification

We provide complete support for Validation master plan, Process validation, Media fill validation, VHP/ EtO validation, cleaning validation, Method validation, Hold time studies, Software/CSV validation.