- Designing the sterile mixing vessels as per highest cGMP standards with Design Qualification
- Clean environment manufacturing with Factory Acceptance Test facilities
- Providing custom required Automation as per MCA & 21 CFR Part 11
- Efficient Micro Filtration System of sterile application with pumping system
- Providing required sterile accessories
- Providing qualification documents like DQ, FAT & Protocols of IQ & OQ.
- “CE” marked Equipments are offered with Third Party Inspection & All Electrical Control with ERTL
- Serail lyophilizers are customized to exact application, designed for precise quality control, operator convenience, efficient production cycles, easy maintenance, best validation, shorter cycle times and speedier deliveries and bottom line- best return on investment.
Pharmalab manufactures Pure Steam Generators to meet cGMP requirements. Condensate of this pure steam produced does meet all pharmacopoeial requirements of WFI like USP, IP, BP and JP. The plant is manufactured as per FDA current Good Manufacturing Practices (cGMP) and ASME requirements.
- The Sterility Test Isolator SKANFOG® STI is the most advanced isolator for testing pharmaceutical samples for sterility (STI). Installation in labs and an accelerated decontamination time are facilitated by the once-through air handling system and the integrated catalytic converter for H2O2. The availability of the isolator has improved substantially, so a high testing frequency can be obtained.
Our plant is designed to be crevice-free as crevices promote stagnation and stimulate bacterial growth. All columns are designed to ASME specifications and are approved by CE for PED regulations as per European Union requirements.