CG Pharma Production
Chemistry in the cleanroom.
Production in the Grade C & D cleanroom according to §13 of the German Medicinal Products Act (AMG) under GMP conditions.
In our cleanroom production, we rely on perfect interaction between technology and people. The production of pharmaceutical media uses technical equipment that meets the highest standards.
Production under cleanroom conditions
Grade C and D.
Filling, decanting, dilution, mixing – our production under Grade C and D cleanroom conditions makes us a specialised partner to the pharmaceutical industry.
We offer the service of this production at the Laatzen site. We are one of the few companies that can also handle hazardous substances in the cleanroom and produce innovative, flexible solutions for our customers in the pharmaceutical industry. We are geared towards the pharmaceutical needs of tomorrow and offer solutions for the pharmaceutical, biotech and medical device industries according to individual specifications.
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.
Wasser für Injektionszwecke (WFI) Leistungsdaten
Produktion: 500 L/h
Lagertank: 5.000 L
Entnahmemenge: max. 7.000 L/h
Spezifikation (EP/USP)
TOC Online: ≤ 500 ppb
Leitfähigkeit Online: ≤ 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
Qualitätssicherungssystem
Bei Qualität gibt es keine Kompromisse.
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
We are a classic contract manufacturing organisation. Manufacturing takes place in a GMP-certified environment. 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.
Mixing, processing and repackaging of liquid and solid materials, container capacity up to 5,000 litres per batch (stainless steel/PVDF), and manufacture of standard and customer-specific buffers for upstream and downstream applications.
With our individual packaging concepts, we offer solutions for transport that are both innovative and sustainable.
