Team of Experienced SME for sterile pharma & Bio pharma

More than 25 years of Experience in following activities.

Design of process solutions for Biopharma: –

– design of Bioreactor – P & ID

– Design of Fermenter – P & ID

– Design of Process Vessels. P & ID

– Multiple design options for Bio kill systems.

– Design of Integrated process solutions for aseptic transfers CIP, SIP circuits. – P & ID

Design of Process solution for sterile pharma- SVP, LVP, ophthalmic, Microspheres

– Design of compounding, filtration mixing vessels – P & ID.

-design of process solutions for septic transfer from compounding to filtration to filling Line, recirculation, respective CIP, and SIP.

CIP: – Depending on the requirements, layout, various combinations design of CIP. Master CIP, Local CIP, Tankless CIP_ like multiple design options.

Qualification / Documentation: –

– Designing of all Qualificator document like URS, DQ, IQ, OQ, PQ, IOQ, SLIA, SRA, QAP etc.

– SMP, VMP

– FAT etc

Technical Finalizations: –

– Technical discussions with supplier.

– Review of all vendor documents, BOQ finalization

– Technical Bid Analysis (TBA), Commercial Bid Analysis (CBA)

– Technical compliance to URS, Technical comparison

– Technical recommendation.

Inspection / Qualification: –

– Execution supervision for FAT, SAT, IQ, 0Q, PQ etc

Automation: –

– Review of control philosophies/ Design of Contral philosophies

– Review of screens, navigation of screen

– Review of process sequences – Batch Test.

– Review of Interlocks, alarms.

– Review of user management as per GAMP.

Facility

– Design of Cleanroom Layout

– Man – material movement desiga

– Design of facility qualification document/ protocol. facility qualification DQ, IQ, OQ,  FQ.

Deviation Management: –

– Gap analysis, Deviation report.

RCA

– CAPA

– Change control

Team of More than 25 years of Experienced SME for sterile pharma & Bio pharma.