Equipment
Switzerland
In addition to four process research and development laboratories our state-of–the-art infrastructure includes manufacturing capabilities for small batch sizes of up to 10-15 kg. The specialised laboratories and kilo-scale manufacturing equipment are designed to operate safely at or below 1 μg/m³ OEL. This specification allows safe handling of highly-potent compounds of all categories including cytotoxics /cytostatics.
Our manufacturing equipment at intermediate scale of up to 630L currently operates at or below 100 μg/m³ OEL.
Our facilities and equipment include:
- Laboratories designed to operate at or below 1 μg/m³ OEL: Air Cleanliness Class ISO 7 (Class 10,000) utilizing barrier isolation technology
- 4 Reactors from 100 L to 250 L (hastelloy and glass-lined), temperature range from -100°C to +160°C, pressure up to 12 bar
- Hastelloy filter drier in glove box (0.125m²)
- Intermediate-scale production facility designed to operate at or below 100 μg/m3 OEL utilising “split-butterfly valve” and barrier isolation technology:
- 3 Reactors from 250 L to 630 L, temperature range from -100°C to +160°C, pressure up to 25 bar
- Hastelloy Filter Dryer (0.25 m²)
Bavla
With the dedicated expansion in Bavla, India – scheduled to start operations by end 2009 – our large scale manufacturing capabilities will allow a safe operation at or below 1 μg/m³ OEL on a scale up to 1600L producing batches in the 200kg range.
- Large-scale production facility designed to operate at or below 1 μg/m³ OEL utilising barrier isolation technology.
- 4 segregated high potency handling cells of which 2 initially will be equipped
- Each cell containing 3 reactors from 630 L to 1600 L and a Hastelloy Filter Dryer (1.0 m²)
- Charging and discharging of reactors and stirred filters via isolators
- Expansion possibilities up to 6300L
- Particle size reduction capability
- Lyophilization capability
