Laboratory

Der direkte Draht: +49 241 51 00 50 - 0

ADVANCED ANALYSIS AND EFFICIENT CONSULTATION

Microbiological tests are carried out in our ultra-modern facilities, and chemical and physical tests are provided in cooperation with our competent partner laboratories.
With a wide range of laboratory services, GfPS can be seamlessly integrated into all your research and development projects. As well as testing the normatively regulated parameters, we also develop customised solutions for your individual needs. In addition to laboratory analysis and measurement technology, we also place an emphasis on providing expert advice in all hygiene-relevant areas:

MICROBIOLOGICAL ANALYSIS
HYGIENE SERVICE
TRAINING
AUDITS

gfps-labor

SERVICES

Pharmaceutical and medical products: Production conditions

  • Examination of the cleanrooms / ventilation facilities for continued compliance with DIN EN ISO 14644 and the guidelines for good manufacturing practice (EU GMP)
  • Hygiene examination of production conditions and determination of hygiene status
  • Quantitative determination of bioburden in accordance with DIN EN ISO 11737-1
  • Testing for bacterial endotoxins (LAL test), gel clot and turbidimetric method (Ph. , USP)
  • Germ differentiation and identification
  • more

Pharmaceutical and medical products/devices: Monitoring / validating sterilisation processes

  • Monitoring and validation of sterilisation processes
  • Testing for sterility according to Ph. Eur., USP
  • Testing of sterility in accordance with DIN ISO 11737-2
  • Validation, revalidation and performance evaluation of sterilisation processes (radiation, steam, ETO and plasma sterilisation)
  • Microbiological examination of sterilisers

Pharmaceutical and medical products/devices: Cleaning, disinfection and conditioning processes

  • Validation of disinfection cleaning processes in accordance with DIN EN ISO 15883
  • Microbiological examination of disinfection cleaning machines

Pharmaceutical and medical products/devices: Testing according to European Pharmacopoeia / USP / other standards

  • Antimicrobial Effectiveness Testing
  • Testing for the absence of certain micro-organisms
  • Determination of total aerobic bacteria
  • Testing for bacterial endotoxins (LAL Test)
  • Sterility testing
  • Testing the antimicrobial effectiveness of surfaces and solid bodies
  • Agar diffusion test in accordance with Ph. Eur., DIN 58940-3, DIN EN 1104
  • Suspension test in accordance with ASTM E 2149
  • Testing in accordance with JIS Z 2801, ISO 22196
  • Testing in accordance with ASTM E 2180
  • Testing in accordance with JIS L 1902

Pharmaceutical and medical products/devices: Packaging Testing

  • Packaging tests according to DIN EN ISO 11607-1
  • Visual inspection (ASTM F1886 / F1886M)
  • Accelerated aging (ASTM F1980)
  • Mechanical stress (ASTM D6179, ASTM D4169)
  • Microbiological dusting (for assessing the microbial barrier) peel test (DIN EN 868, part 5)
  • Determination of the seal seam width (DIN EN 868, part 5)
  • Tensile strength testing of sealed seams (DIN EN 868, part 5)
  • Testing for permeability and continuity of sealing (ASTM F1929, ASTM F3039)
  • Testing for fine holes in the plastic composite foil (DIN EN 868, part 5)
  • Testing of germ impermeability (DIN 58953-6)

more

Hospitality and medical practice hygiene

  • Testing of ventilation systems in accordance with DIN 1946 including microbiological environment analysis and assessment
  • Microbiological testing of sterilisers and disinfection cleaning machines. Detection and enumeration of Legionella according to ISO 11731

Laundry / textiles

  • Micro-biological wash-cycle monitoring
  • Microbiological water tests to determine the hygienic status
  • Determination of microbial contamination (bioburden) of textiles with an exceptionally high requirement for low microbial count
  • Microbiological testing of disinfection machinery and cycles
  • Microbiological testing of sterilisers

Washing and disinfection agents

  • Microbiological examination in accordance with relevant regulations, e.g. DGHM-Directive, DIN EN 1276, DIN EN 1040, DIN EN 1275, DIN EN 1650
  • Quantitative suspension testing to evaluate the bactericidal and/or fungicidal activity

Environment

  • Mould fungus differentiation and identification
  • Antimicrobial suspension test for evaluation of bactericidal and /or fungicidal activity

PHARMACEUTICALS

The pharmaceutical industry traditionally has particular high quality standards. We reliably support our customers from the pharmaceutical industry in achieving these goals.

GfPS is GMP certified. The GMP document (certificate) certifies that we, as a pharmaceutical testing laboratory in the sense of § 14 (4) of the German Medicines Act (AMG), are permitted to carry out microbiological quality control tests, particularly sterility testing and endotoxin tests, and fulfil the requirements of the EC Guide to Good Manufacturing Practice for Medicinal Products.

MEDICAL DEVICES

Medical devices require standards that are similarly high to those for pharmaceuticals. We support you in product analysis as well as in planning, testing and optimisation of your production conditions.

The range of medical products and devices is extremely varied, ranging from contact lens care products and bandages to dialysis machines and catheters.

Due to the accreditation at DAkkS (certificate) according to DIN EN ISO/IEC 17025, Directives 93/42/EEC and 90/385/EEC in the areas of microbiological-hygienic testing of medical devices including sterilisation procedures and environment monitoring, the tests carried out by GfPS in this area are recognized for conformity assessment throughout Europe.

COSMETICS

The requirements for the production of cosmetics have increased enormously: On the one hand, consumers expect first-class products of consistently high quality, and on the other hand legislature requires GMP conditions in production. We advise our customers in the cosmetics industry as an experienced, competent partner. Our common goal: efficient production processes and high-quality end products.

HOSPITAL / MEDICAL PRACTICE HYGIENE

In the area of hygiene in hospitals and medical practices GfPS mbH provides monitoring of environmental conditions. Additionally, the equipment for sterilisation and disinfection can also be inspected. From the shipment of biological indicators and advice on local use to the evaluation of the appropriate test systems – GfPS is at your side to advise you.

LAUNDRY

Our analytical services include efficacy studies of detergents and cleaning products for various uses (clinical, food, industrial, domestic, public facilities, etc.) as well as microbiological testing of disinfection machinery and cycles and micro-biological wash-cycle monitoring.

TEXTILES

Modern functional textiles must deliver maximum performance. We check the effectiveness of your products and determine the hygiene-relevant parameters. With modern textile analysis, we support you with the quality assurance of your production, e. g. the determination of microbial contamination (bioburden) of textiles with an exceptionally high requirement for low microbial count

ENVIRONMENT / WASTE WATER / MOULD

There are several aspects of environmental analysis that are generally summarised in the term “environment”. These include the analysis of wastewater samples as well as the identification of species in the domain of mould analysis. Our years of experience and the annual training of our professionals in this area ensure our continued expertise and the high quality of your analysis results.

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