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Medical Device

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Medical Device -Pharmaceutic Testing

The medical device industry is highly regulated and requires quality systems to be assessed for products to be manufactured. From stents to regenerative medicines, the medical device manufacturing sector is highly diversified and is known for producing high-quality products using advanced technology.

To support your achievement of the necessary standards outlined under regulations and to keep patients safe, Abiolabs offers a team of qualified and experienced microbiologists allowing you to comply within the areas of sterilization, packaging and microbiological testing.We believe that our approach to microbiology and sterilization adds value to your products and helps to ensure that you, our customers, are successful and patients are protected.

Standards and regulations covering this field of activity include:
  • The use of appropriate controlled manufacturing processes that establish a consistent product bio-burden prior to the sterilization process (e.g., use of clean rooms and/or controlled environments)
  • Validation and control of the primary packaging process to assure the integrity of the sterile pack
  • The validation and control of the sterilization process.
We perform hypenic qualification of production facilities, microbiological tests on products before and after sterilization. Our Medical Device/Pharmaceutical Testing Services include : 
  • Determination of bioburden before sterilization
  • Sterility testing according to USP and EP of products and biological indicators
  • Method development and validation
  • Endotoxin testing
  • Environmental monitoring of production zones

Viable and nonviable particulate analysis

Contact plate and swab analysis of surfaces

  • Package expiration dating studies (aging studies)
  • Container Closure Permeation
  • Dye and microbial ingress studies

Our Services

Bioburden
validation test

The Bioburden test determines the total number of viable microorganisms in or on a medical device, container or component. 

Bioburden test

The Bioburden test determines the total number of viable microorganisms in or on a medical device, container or component.

Sterility test

The product sterility is necessary for medical devices, pharmaceuticals, preparations, tissue materials and other materials 

Biological
indicator reading

Biological Indicator ReadingA biological indicator (BI) is the only type of monitor that provides direct evidence that sterilization process conditions are sufficient to kill spores.

Microorganism identification

Microorganism IdentificationThe organism identification tests are used to characterize and identify microorganisms detected on non-selective agar media

Surface Monitoring

Monitoring the microbial flora of environmental surfaces, manufacturing plants, and equipment is an important stage in achieving Good Manufacturing Practices

Air Monitoring

ur environmental analyses services include testing indoor and outdoor environments for the presence of microbiological contamination

Endotoxin / LAL

Bacterial endotoxins are lipopolysaccharides (LPS), components of Gram-negative bacterial cell walls known to cause fevers and disease 

Particulate matter 

Particulates that may be present on intravenous medical devices such as guidewires, catheters, and stent delivery systems pose potential health risks to patients.

Packaging testing

Package integrity testing is important in determining the sterility and the shelf life of a medical device or product. 

Abiolabs is a spin-off from one of NATEC Medical’s division and have been designed as per Good Laboratory Practices.

© Copyright 2019, Abiolabs

6th floor Maeva Tower, Silicon Avenue, Ebène Business Park, Réduit 72201, Mauritius.

Monday – Sunday 08:00-19:00.

 (+230) 465 1414