Contamination Control Strategy (CCS)
A suitable Contamination Control Strategy (CCS) is an extremely critical success factor for process reliability in the manufacture of sterile products, as the quality of the end products is significantly influenced by the production conditions. Based on the experience of the last 35 years and the involvement in numerous qualification projects, Labor LS offers a logical overall concept for the prevention of microbiological, pyrogenic and particle contamination.
Labor LS customers benefit from the broad microbiological and analytical expertise in a GMP environment. Identifying and counteracting the pitfalls in the implementation of CCS concepts at an early stage: with over 7000 sqm of laboratory space up to cleanroom class A level, Labor LS is in itself a "heavy user" and can draw on a wide range of know-how.
All from a single source: we can offer you convincing integrated solutions, ranging from concept development, on-site services, and logistics solutions to the analytical portfolio in the laboratory.
Our services for your qualification and contamination control strategy
- Development of industrial hygiene sampling plans for qualification and routine monitoring
- Development of a personnel hygiene concept Including training of the employees
- Taking on the qualification of nutrient media
- Sampling on-site
- Transfer of samples to Labor LS via own, actively conditioned logistics fleet
- Individual evaluation of the hygiene samples
- Identification of microorganisms for the determination of the house germ flora
- Validation of disinfectant efficacy taking into account the individual surfaces and house germ flora
- On-site sampling of:
- AP water
- WFI
- Ultra-pure steam
- Potable water
- Transfer of samples to Labor LS via own, actively conditioned logistics fleet
- Incubation and evaluation of media fills
- Evaluation of bioindicators
- Determination of bioburden
- Validation of heat tunnels and stopper washers
- Container Closure Integrity Tests
- Testing of Single Use Systems
- Testing for absence of DNases/RNases
- Bacterial retention tests
- Testing of raw materials (chemical, physical and microbiological)
- Testing of intermediate products
- Release of finished products:
- Sterility tests (also microbial count tests)
- Endotoxin testing
- Mycoplasma detection
- Sub-visible particles
- Development of industrial hygiene sampling plans for qualification and routine monitoring
- Development of a personnel hygiene concept Including training of the employees
- Taking on the qualification of nutrient media
- Sampling on-site
- Transfer of samples to Labor LS via own, actively conditioned logistics fleet
- Individual evaluation of the hygiene samples
- Identification of microorganisms for the determination of the house germ flora
- Validation of disinfectant efficacy taking into account the individual surfaces and house germ flora
- On-site sampling of:
- AP water
- WFI
- Ultra-pure steam
- Potable water
- Transfer of samples to Labor LS via own, actively conditioned logistics fleet
- Incubation and evaluation of media fills
- Evaluation of bioindicators
- Determination of bioburden
- Validation of heat tunnels and stopper washers
- Container Closure Integrity Tests
- Testing of Single Use Systems
- Testing for absence of DNases/RNases
- Bacterial retention tests
- Testing of raw materials (chemical, physical and microbiological)
- Testing of intermediate products
- Release of finished products:
- Sterility tests (also microbial count tests)
- Endotoxin testing
- Mycoplasma detection
- Sub-visible particles
Discover the benefits of collaboration
- Expertise and experience from the LS Labor Competence Center
- State-of-the-art technology and equipment for accurate findings
- Broad spectrum of services with a synergistic effect
- Efficiency and reliability
- Individuality: every project is unique.
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