Manufacturing facilities and processes can be a primary source of product contamination. EUROLAB, offers a range of services to assess these manufacturing environmental conditions, in addition to water system verifications, raw material screening, and residual manufacturing material testing.
Environmental monitoring involves inspecting the essential components of a controlled environment, including water, air, surfaces, equipment, and personnel. EUROLABoffers environmental monitoring materials (surface, air plates) and water monitoring materials (bottles with and without thiosulfate) to evaluate microbial controls in production facilities. Testing services for plates and water samples can be submitted to the laboratory for analysis.
For pharmaceutical and liquid products requiring sterile processing EUROLABoffers filter validation services to evaluate a filter's ability to remove chemicals or microbial organisms of various sizes. This test allows manufacturers to determine membrane pore sizes and is an excellent lot release test in compliance with both ASTM F838-05 and HIMA guidance documents.
Screening of raw materials as part of incoming supply quality checks is an important part of manufacturing production and process controls. Depending on the type of material or supply, the manufacturer may engage in qualitative evaluation of parts to assess microbial content (sterile and non-sterile), material composition and changes in materials. EUROLAB offers both analytical and microbiological tests to make these evaluations. Additionally, relatively inexpensive qualitative tests can be performed to ensure raw material biocompatibility, such as the cytotoxicity MEM elution assay.
Cleaning validations examine the overall surface cleanliness of newly manufactured medical devices and single-use implants, targeting contaminants left over from manufacturing and cleaning processes. Note that just because a device is sterile does not necessarily mean it is clean.
Test methods are available to measure the amount of residue (ie oils, lubricants, polishing compounds, detergents and passivation residues) on the device or implant. To give a comprehensive view of cleanliness, you can also add a cytotoxicity assessment and tests to examine microbiological contamination.
Water is one of the most common sources of product contamination, and any product manufacturing process that uses water in the final product as part of cleaning or processing should be evaluated, controlled and monitored. Determining the frequency of water change during passivation processes is also important to minimize microbial contaminants and bacterial endotoxin levels in finished medicinal products. EUROLABprovides consultancy services for the installation of new water systems, validation test plans and testing services to evaluate water system microbial and chemical content.
EUROLAB, with its highly expert team and internationally accredited laboratories, Pharmacological Plant and Process Validation It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
