Pharma

pharma

Pharma

Pharmaceutical products are regulated by the pharmaceutical legislation including GMP. The corresponding requirements for products and manufacturers are very high. Our expertise contains the testing and registration of pharmaceutical products in the field of infection prevention and wound care. Furthermore, we offer you our consulting, training and laboratory services for microbiological quality controls, validation of cleaning and disinfection processes as well as general hygiene of your facilities.

Laboratory

Type Number Title
 
Toxicity

OECD 471

AMES test to test mutagenicity

 
Environmental control

DIN 10113-1*

Determination of surface colony count on fitment and utensils: Quantitative swab method

 
Environmental control

DIN 10113-2*

Determination of surface colony count on fitment and utensils: Semiquantitative swab method

 
Environmental control

DIN 10113-3*

Determination of surface colony count on fitment and utensils: Semiquantitative method with culture media laminated taking up equipment (squeeze method)*

 
Environmental control

In-house method*

Determination of airborne microbes by air sampler*

 
Environmental control

In-house method*

Determination of airborne microbes by sedimentation method*

  • Consultancy for manufacturers of pharmaceutical products

    As your external microbiological department we will support you by offering comprehensive consulting services covering all your questions concerned with hygiene and microbiology in the field of general hygiene, process water hygiene, personnel hygiene, microbiological quality control and preservation of pharmaceutical products.

    For products within your core competency "infection prevention and wound care" we can assist and support you with the registration process starting from the idea till the final registration is done. The issuance of the registration documents will be done by our well-known partner YES Pharmaceuticals (Link). Products can be e.g.: 

    - Hand and skin disinfections (if classified as pharmaceutical product)

    - Wound antiseptics

    - Mucosa membrane antiseptics

    - Antiseptically rub and lotions for the treatment and prevention of infections such as burns

    In addition, we also advise you with the optimization and/or restructuring of our cleaning and disinfection processes in your facilities. We also validate these facilities by involving our laboratories.

    Production plant in the pharmaceutical industry

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Are you interested in our services?

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