SPECTRUM PHARMATECH CONSULTANTS - NEW COMPANY PROFILE

Case Studies
Active Pharmaceutical Ingredients
CEPHALOSPORIN CRYSTALLINE STERILE BULK FACILITY
Parabolic Drugs Limited, Derabassi, Punjab.
The facility is designed to produce
'Cephalosporin Crystalline Sterile Bulk' and
has a total built up area of about 1600 Sq.M.
The main block is designed as a ground plus
two storey structure with warehouse and
production area on Ground floor, Technical
area for placement of AHU on first floor and
Utility area on second floor
SCOPE OF SERVICES:
Concept Design, Basic Engineering, Detail Engineering,
Procurement Assistance,
The operations carried out in the sterile area
i.e. from crystallization step onwards thru to
Drying, Filling and Packing is fully
automated and is procured from Omca
Plants Srl. (BA.DO.), Italy.
MULTI PRODUCT SMALL SCALE PRODUCTION & KILO LAB FACILTY
Enaltec Labs, Ambernath, India
The facility was designed as a Multi-Product Small Scale
Production & Kilo Lab facility for manufacturing APIs.
The proposed facility was planned, designed and engineered as
per cGMP standards of international authorities like USFDA,
WHO etc. and confirms to all relevant local statuary/regulatory
and cGMP requirements. The facility design complies with ICH,
NFPA & ISPE guidelines. The facility has eventually received
approval by USFDA.
The project comprised of setting up of Production Block,
Warehouse & Quality Control Block. In addition, the facility has
all necessary ancillary structures like Utility Block, Solvent Drum
Yard, Transformer Yard and Effluent treatment plant.
SCOPE OF SERVICES:
Basic Engineering , Detail Engineering, Procurement
Assistance, Inspection & Expediting, Construction
Management, Validation Support
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