These services complement pharmaceutical production and provide valuable added benefits.
FULL-SERVICE FOR YOUR SUCCESS
Laboratory Service, Scale-Up & Transfer
More services of KLOCKE Pharma-Service
Laboratory services
Analytics and microbiology
KLOCKE analyses incoming raw materials and finished products in-house for approval. Finished products are released for packaging or to the market. Bulk materials, active ingredients and excipients are tested by our experts according to their monographs or to the customer’s dossier.
In addition, our range of services includes:
- Establishing methods
- Method validation
- Method transfer
- Stability tests
You can rely on our certified partner laboratories for some services that we do not carry out in-house such as gas chromatography, AAS, particle testing using Malvern or SEM, microbiological tests, etc.
Stability studies
Analysing the minimum shelf life of your new product as well as regular verification of established data are regulatory requirements. We offer stability studies for determining shelf-life, active ingredient efficacy, and the long-term safety and stability of your product. This includes:
- Calculation of the required test samples
- Coordination of the batch sampling during production
- Creation of stability tables and test plans
- Storage of the stability samples in climatic chambers
- Analysis and evaluation of the tested stability samples at the given time
- Writing of the stability report
Temperature and humidity conditions in the climate chambers:
- 25°/60% rel. humidity
- 30°/65% rel. humidity
- 40°/75% rel. humidity
Scale Up & Transfer
Scale-up
The scale-up of small batches is carried out in the KLOCKE technical centre. The manufacturing processes available in the technical centre are identical with those of our industrial production premises.
Transfer / Validation / Market release
KLOCKE´s full-service concept encompasses the complete transfer of your products on our production lines. Our experts supervise and implement all necessary steps. From the validation of new manufacturing processes to the market release: we organise all administrative steps and, finally, take on the responsibility for the products manufactured by us.
At KLOCKE, we offer a range of services to support you, including product transfers, manufacturing validations, multilingual manufacturing instructions, and market release.
