CG Pharma Production
Production in the cleanroom, Grades C and D.
We offer our customers the standardised or individualised production and mixing of solids and liquids – in accordance with GMP/AMG §13.
Production uses technical equipment that meets the highest standards. Depending on the medium to be manufactured, batch sizes of up to 5,000 litres can be produced in stainless steel or PVDF batch tanks. Validated manufacturing processes enable homogeneous and reproducible quality for each individual batch produced. What sets our pharmaceutical production apart is the handling of hazardous substances in the cleanrooms.
Production of Liquid Substances
Mixing tanks: Plastic and stainless steel: 2000 l and 5000 l
Magnetically coupled mixers
Tanks with integrated scales for direct weighing of ultrapure media AP and WFI
Cleaning-in-place (CIP) of containers and product lines
Direct addition of solids and liquids
Can be blanketed with nitrogen
Online temperature measurement
Online measurement of pH level
Direct filling and weighing of media
- Container filling from 1 l to 20,000 l
- Single-use bags from 500 ml to 1000 l
- Small containers: 5 l - 25 l | up to 600 l/h
- Drums and IBCs: 60 l - 1000 l | up to 5000 l/h
- Tankers: up to 20,000 l
Production of Solids
Weighing of solids
Mixing of solids up to 600kg
Filling and transfer of solids from 5 kg to 60 kg
Grinding and classification of powders and granules
Grinding and classification of solids
Purified water
AP & WFI water for injection.
We produce purified water and water for injection according to EP/USP. In stainless steel and plastic tanks with a useful volume of up to 5,000 litres, versatile solutions and mixtures can be produced and filled in a wide range of container sizes.
Water for injection (WFI) performance data
Production: 500 l/h
Storage tank: 5,000 l
Extraction volume: max. 7,000 l/h
Specification (EP/USP)
TOC online: ≤ 500 ppb
Online conductivity: ≤ 1.3 µS/cm
Purified water (AP) performance data
Production: 4,000 l/h
Storage tank: 10,000 l
Extraction volume: max. 7,000 l/h
Specification (EP/USP)
TOC online: ≤ 500 ppb
Online conductivity: ≤ 1.3 µS/cm
Quality Assurance System
There are no compromises when it comes to quality.
Continuous improvement
- Management review
- Complaints procedure
- Product quality review (PQR)
- QA check BRR
- Supplier and service provider qualification
- Audit system
- Training system
Risk-based management
- Change control system
- Deviation management
- OOS system
- CAPA system
- Risk management according to ICH Q9
Qualification and validation according to Annex 15 EU GMP Guidelines
- Room and plant qualification
- Software validation
- Process, cleaning and method validation
Quality control
Multi-compendial physical and chemical tests
End product testing according to customer requirements
Microbiological tests
Elemental impurities analysis of (ICP)
Stability testing according to ICH guidelines
Typical areas of application
- Cleaning and rinsing solutions (CIP media)
- Disinfection of process liquids
- pH value adjustment
- Chromatography steps for media and buffer preparation
- Production of monoclonal antibodies
- Production of recombinant proteins
- Vaccines and antibody-drug conjugates
- Cleaning of stainless steel equipment
- Protein purification/stabilisation
- Virus inactivation
- Diafiltration and purification buffers
