Potent Compound Experience
Case Studies
IPS provides comprehensive potent
compound services to support the safe
handling of active pharmaceutical
ingredients, including:
- Industrial Hygiene
- Equipment Design
- Facility Design
- Compliance/Validation
Project Profile: Cytotoxic Commercial
Mfg. Facility Basis of Design
Objective
Construct a new dedicated manufacturing
facility for the production of OSD and
Parenteral cytotoxic pharmaceutical
products.
Capabilities
The new cGMP facility included two
dedicated areas, one for oral dosage and
the other for parenteral products for
international market distribution. Solid
dosage capabilities included wet and dry
granulation through compression,
coating, and final packaging. Parenteral
operations supported formulation and
primary and secondary packaging. Various
isolation technologies were assigned to
provide for primary containment and
facility elements provided transition
area supporting secondary containment
and cGMP zoning (FDA , EMEA, MHRA, WHO).
Produced materials will be used for both
submission and commercial use with batch
sizes ranging from 0.75kg to 60kg.
Location
India
Size
35,000 Square Feet
Services
Potent Compound & cGMP Risk Assessment,
Design Philosophy, Process Equipment URS
& Specifications, Conceptual Design,
Detailed Design, Construction
Administration, Validation Master Plan;
Compound Evaluation/Categorization (OEL)
Result
IPS developed a risk-based approach to
design the facility to include for the
protection of both product and
personnel.
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