At a glance:
- Extracts, GMP-compliant manufacturing
- Ready-to-use medicines
- Small batches supported
- Approval analysis
- Approval by Quality Inspection (according to AMWHV)
Contract manufacturing to GMP guidelines and AMWHV
Dr. Gustav Klein has extensive experience in developing and manufacturing herbal agents. GMP-compliant manufacturing facilities and air-conditioned production halls equipped with microbe monitoring ensure the highest possible quality. Development and storage of the products is in full compliance with GMP and other applicable guidelines.
Aqueous and ethanolic aqueous
- Fluid extracts
- Filtration (EKS)
- Concentration (vacuum)
Preparations are kept in stainless steel vessels of 50 to 1,000 litres.
- Wet granulation (also in vacuum)
- Dry granulation
- Powder blends and screenings (from 20 to 600 kg)
- Tablets (up to 200,000/h) - uncoated from 5 to 13 mm, coated (tablets, capsules)
- Capsules in all standard sizes.
Filling and packing
We have one filling and packaging line for liquids (vials of 20 to 100 ml) and one for solids. Our products are filled in laminar flow conditions. We have fully automatic filling in standard packaging – cartons with leaflets, bundling – including automatic weight control.
We also provide manual filling and packing for smaller batches.
- Continuous temperature monitoring with 7/24 emergency support
- Modern labelling and identification systems – barcodes – on stored products using proven warehouse management software and batch-oriented materials management
- Proven computer-controlled storage and retrieval
Storage according to Ph.Eur. at 25°C
One and a half thousand pallet spaces
Storage according to Ph.Eur. at 2–8°C available
Cold store dimensions: 5.4 x 5.3 x 5.0m (LxWxH)
Thirty-four pallet spaces
GMP temperature monitoring with alarms when temperatures rise or fall beyond the allowed tolerance limits