Oncology Injectables — Manufacturer & Supplier
Cytotoxic and cytostatic injectables in a contained, dedicated suite — liquid vials and lyophilised presentations.
Cytotoxic products cannot share a line with anything else, so this capability sits in a dedicated suite with its own air handling, negative-pressure cascade to the corridor, isolator or restricted-access barrier filling, and separate gowning and material airlocks. Operator exposure is managed to a defined OEL band with containment verified by surrogate monitoring rather than assumed. Both liquid-fill and lyophilised presentations are supported, with cleaning validation to product-specific MACO limits and swab recovery data on every contact surface. Waste, effluent and spent gowning follow a cytotoxic route through to a licensed disposal contractor. Listed formulations describe manufacturing capability and qualified facility scope. They are not an offer of approved or marketed products, and any supply is subject to the customer holding the applicable marketing authorisation for the destination market.
Manufactured under the Stancor Pharma brand by Stancor Pharma.
Specifications
- Formulation classes (capability)
- Generic cytotoxic injectables — taxane, platinum, anthracycline, antimetabolite and vinca classes
- Presentations
- 2-50 ml liquid vials, lyophilised vials, ready-to-dilute concentrates
- Containment
- Dedicated suite, negative pressure cascade, isolator/RABS filling, OEB 4 handling
- Batch envelope
- 10 L to 300 L liquid; 1,000 to 40,000 vials per lyophilisation cycle
- Cleaning validation
- Product-specific MACO with swab and rinse recovery, HPLC-verified
- Release testing
- Assay and related substances (HPLC), water content (KF) for lyophilised, BET, sterility, CCIT
Oncology Injectables Applications
- Hospital oncology supply
- Day-care chemotherapy
- Tender supply
- Export markets with cytotoxic GMP requirements
- Comparator & clinical supply
Applicable Standards & Specifications
- WHO-GMP
- Schedule M (CDSCO)
- EU-GMP Annex 1
- ISO 14644 cleanrooms
- USP <800> handling principles