Services

Quality Control & Laboratory Investigations

One of our core competencies is to provide specific solutions that enable our clients to aptly fine tune their business model and out-sourcing needs. With over 90% retention of sponsors, we take pride in offering them the best of our services and continually grow with them to adapt to their requirements and needs.

We segment our laboratory services into 2 broad domains:

Quality Control Testing

  • Raw Materials
  • Finished Products
  • Medical Devices
  • Cosmetics

Laboratory Investigations

Quality Control Testing

Pharmacopoeial & non-pharmacopoeial chemical & microbiological tests routinely on a large scale basis for pharmaceutical products & medical devices in compliance with GMP-GCLP.

We combine chemical and microbial product knowledge with Quality Control Testing, Method Development and Validation Studies for finished formulations, active pharmaceutical ingredients (APIs), excipients and medical devices.

With in-house GMP accredited cleanrooms of 500 m2 class D-A, one of the 3 in the Benelux-Germany area, all our microbiological studies are performed within & our service range includes Sterility Testing, Endotoxin Testing and Mycoplasma Testing

With our state-of-the-art laboratories we offer a complete range of services including chromatography facilities (HPLC, UPLC, GC, LC-MS and TLC), spectroscopy (UV and IR) dissolution testing and GMP certified class A - D clean rooms – in which all Microbiological investigations are carried out.

Routine Quality Control Tests include: (pharma and cosmetics)

  • Testing of Cytostatics
  • Complete Pharma-Chemical Testing
  • Bioburden testing, Sterility Testing, Endotoxin Testing, Antibiotics Assay, Preservatives Testing

Medical Device Testing packages include

  • Testing of Biocontainers, Testing of Sterile Implants, Accelerated ageing Studies, Sterilisation validation of Gamma Irradiation Processes, Particulate Matter, LAL testing

Standard Throughput times vary, depending on the methods used but on an average are between 8-17 working days. Express services can also be performed in 3-5 working days based on the requirement – if the methods of analysis permit.

The laboratories are currently evaluating & devising “Rapid Analysis” techniques through which the standard throughput time is reduced 3-5 fold. These techniques are specifically aimed at Sterility Testing and UPLC Assays. Please check with us for more information.

Laboratory Investigations

Method Development & Validation Studies are carried out according to international guidelines. We use standard validation packages in conformity with ICH guidance.

A validation project, executed as per GLP guidelines, comprises a study plan, study design, performance of analytical work and subsequent data handling. All data is presented in a detailed study report. Validation studies are performed by dedicated staff with special training on study handling, in accordance with international guidelines (e.g. PhEur, USP, ICH).

Standard Throughput times are between 6-8 weeks.

Please ask us for example reports and more information.

Stability Studies are performed in temperature/humidity controlled and monitored cabinets in compliance with ICH or ASTM guidelines.

Standard chamber conditions include:

  • 25°C ± 2°C / 60% RH ± 5%
  • 30°C ± 2°C / 65% RH ± 5%
  • 40°C ± 2°C / 75% RH ± 5%





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