- Development and production of customised formulations
- In-house R&D department, from laboratory scale to commercial production
- Agile project management, consulting and planning
- In-house chemical/physical analytical laboratory
- Testing of starting materials according to pharmacopoeia (e.g. EP, BP, USP, JP, ChP)
- Finished product testing (e.g. appearance, pH, conductivity, density, refractive index, osmolality, assay)
- Microbiological testing (e.g. sterility, endotoxins, RNAse, bioburden)
- Stability testing
- Manufacturing authorisation according to the German Medicinal Products Act AMG §13
- Quality assurance agreements with customers and suppliers
- Batch release by authorised person
- Risk-based Management
- Risk management system acc. to ICH Q9
- Change control
- CAPA / OOS System
- Continuous improvement
- Product quality review
- Batch record review
- Supplier qualification system
- Audit and training system
- Qualification and validation acc. to Annex 15 EU GMP
- Process, cleaning and method validation
- Room and equipment qualification
- Software validation
IN-HOUSE AP/WFI PRODUCTION
- Purified water (AP) according to EP, USP
- Water for injection (WfI) according to EP, USP
- 20,000 L storage tank (WfI)
- Production capacity: 500 L/h
- 10,000 L storage tank (AP)
- Production capacity: 4,000 L/h
- Continuous monitoring of water quality for compliance with the specification parameters
- 3,200 pallet spaces for packaging materials, raw materials and finished products
- Temperature and humidity monitoring
- Pest control
- Underground stainless-steel storage tank with 30,000 L volume for pharmaceutical solutions
- Laminar flow sampling cabinet for contamination-free sampling of raw materials
PACKAGING FOR LIQUIDS AND SOLIDS
- Filling in custom- designed 2D and 3D single-use bags/manifolds
from 1 L - 1,000 L - Multiway transport/bioprocess containers for 3D single-use bags from 100 L - 1,000 L (CG Tainer)
- Various packaging options for liquids: 10 L - 25 L canisters, 220 L PE or steel drums, 1,000 L intermediate bulk containers (IBC), isotainers up to 20,000 L
- Customer-specific multiway packaging with validated cleaning concepts
- Various primary and secondary packaging options for solid raw materials ranging from 1 kg - 25 kg (e.g. plastic pail, cardboard box, PE cross-bottom bag with PE-Inliner)
- GDP-certified pharma logistics
- Temperature monitoring and GPS tracking
- Security against unauthorised access
- Isotainer bulk transport up to 20,000 L, general cargo (packaged goods)
- Customised logistics concepts
- International distribution network
