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Contract manufacturing

PharmIdea's production capacity is up to one million sterile vials per year

Capacity and vial size

Production technology	Main production steps	Vial size ⁽¹⁾	Production batch size
Production technology	Main production steps	Vial size ⁽¹⁾	Cytotoxic products	Non-cytotoxic products
Freeze-drying	Preparation of intermediate product	8 ml	up to 1550	up to 6550
	Sterilizing filtration of solution	10 ml	up to 1150	up to 5470
	Vials aseptic filling	30 ml	up to 490	up to 3430
	Freeze-drying		(depends on freeze-dryer capacity)⁽²⁾	(depends on freeze-dryer capacity)⁽²⁾
	Vials aseptic stoppering and sealing		(depends on freeze-dryer capacity)⁽²⁾	(depends on freeze-dryer capacity)⁽²⁾
Aseptic filling	Preparation of intermediate product	2 ml	Up to 20 L solution volume⁽³⁾	Up to 350 L solution volume ⁽³⁾
	Sterilizing filtration of solution	6 ml
	Vials aseptic filling	8 ml
	Vials aseptic stoppering and sealing	10 ml
		30 ml

Terminal sterilisation	Preparation of intermediate product	2 ml	Up to 20 L solution volume⁽³⁾	Up to 350 L solution volume ⁽³⁾
	Sterilizing filtration of solution	6 ml
	Vials aseptic filling	8 ml
	Vials aseptic stoppering and sealing	10 ml
	Terminal sterilisation by steam	30 ml

(1) Any other size of vials in range 1 – 100 ml may be considered
(2) Batch size for other vials size may be requested separately
(3) More detailed calculation can be done, knowing the specific size of vials and fill volume

Investigational medicinal products (IMP) manufacturing

Sterile IMP (including cytotoxic) manufacturing in vials for phase I – III studies
Clinical trial material labelling, release, dispatching and shipping