QUALITY ASSURANCE

Perfectus Biomed are dedicated to providing a high-quality service to our clients.

Our services are underpinned by our Quality Management Systems, which ensure the confidentiality, impartiality, quality and integrity of our laboratory studies by ensuring product and service quality levels, customer satisfaction and company objectives are achieved.

  

Our laboratory is audited regularly by Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom Accreditation Service (UKAS), British Standards Institution (BSI) and also by our clients to ensure compliance to each of our quality systems:

  1. ISO 9001 certification for the development and provision of standardised and customised microbiological services, biological evaluation, materials testing and site audits.
  2. ISO 17025 accreditation (Competence of Testing and Calibration Laboratories) for EN 1276 and six biofilm test methodologies
  3. Good Laboratory Practice (GLP) compliance in accordance with directive 2004/9/EC.

If you would like to know more about any of the below quality systems, please get in touch. 

ISO 9001;

Perfectus Biomed are certified by BSI to ISO 9001, which is the international standard that specifies the requirements for a quality management system. The standard is used to:

  • Demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
  • Enhance customer satisfaction through effective application of the system.

This is achieved by controlling documentation, resources, infrastructure, work environment, equipment and production using a process-based approach. The ISO 9001:2015 certification brings quality and continuous improvement into the business to achieve the intended results in accordance with the quality policy and strategic direction of the organisation. The standard introduces risk and opportunity management to identify business opportunities that contribute to bottom line improvements.

Please see a copy of our ISO 9001 certificate.

ISO 17025 Accreditation;

Perfectus Biomed were the first laboratory globally to gain UKAS accreditation for six biofilm test methodologies to ISO 17025 (No. 9192); Minimum Biofilm Eradication Concentration (MBEC), CDC Biofilm Reactor, Drip Flow Biofilm Reactor and the Single Tube method. We also have EN 1276 accredited to this standard.

UKAS is the recognised accreditation body for the United Kingdom. They assess organisations that provide testing and calibration services to internationally recognised standards. Accreditation by UKAS demonstrates competence and performance capability of the evaluators. The accreditation requires laboratories to demonstrate that they operate a quality system and generate technically valid results to a global standard to provide consistency.

Please see a copy of our UKAS Schedule of Accreditation.

Good Laboratory Practice;

Perfectus Biomed are a GLP-compliant laboratory, demonstrating compliance with OECD Principles of Good Laboratory Practice. GLP is a quality control system of the processes and conditions under which non-clinical health and environmental studies are conducted, recorded, reported and archived. The GLP quality system uses a set of OECD principles to assure the quality and integrity of laboratory studies and the integrity of data produced by harmonising testing procedures.

As a GLP-compliant testing facility, our laboratory and processes are regularly inspected by MHRA, which includes a review of:

  • GLP quality systems
  • Inspection of facilities
  • Audit of completed and on-going studies

Our statement of GLP compliance can be found here.

Perfectus Biomed offer GLP-compliant, UKAS-accredited in vitro testing to provide the data required to support products through global regulatory processes. Our expertise and knowledge are fundamental to the services we provide. Please get in touch for further information.

Our library of test organisms includes: 

Acinetobacter baumannii
Actinomyces naeslundii
Adenovirus (human)
Aspergillus brasiliensis
Aspergillums niger
Aureobasidium pullulans
Bacillus cereus
Bacillus subtilis
Camplylobacter jejuni
Candida albicans

Candida auris
Clostridium difficile
Corynebacterium minutissimum
Enterobacter cloacae
Enterococcus faecalis
Enterococcus faecium (VRE)
Enterococcus hirae

Escherichia coli
Fusobacterium nucleatum
Haemophilus influenzae
Heliocbacter pylori
Halomonas magadiensis
Klebsiella pneumoniae
Lactobacillus casei
Neisseria gonorrhoeae
Neisseria subflava
Porphyromonas ginigvalis
Prevotella nigrescens
Propionibacterium acnes
Proteus mirabilis
Pseudomonas aeruginosa
Salmonella enteritidis
Shigella dysenteriae

Staphylococcus aureus (MRSA and MSSA)
Staphylococcus epidermidis
Staphylococcus haemolyticus
Stenotrophomonas maltophilia
Streptococcus mutans
Streptococcus oralis
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus zooepidemicus
Tannerella forsythia
Trichophyton rubrum
Veillonella dispar

WHO Priority organisms.
ESKAPE pathogens.

Other- please ask.

Medical Devices

We can use the PMM to test for bacterial adhesion to and host cell toxicity of experimental devices.

Learn more here

 

Urogenital Health

Since much of the human genital tract is composed of mucosal tissue, the PMM can be used for predictive preclinical testing of compounds or products related to urogenital health.

Learn more here

Inflammation and Biocompatibility

The PMM offers a unique way to investigate inflammatory cytokine concentrations in a cost-effective manner. We can perform ELISAs and multiplex assays to determine whether experimental compounds are pro- or anti-inflammatory.

Learn more here

Infectious Diseases

Mucosal tissue is an ideal environment for microbial growth, making the PMM an excellent application for testing the efficacy of products to treat infectious disease pathogens. We can test for efficacy against planktonic and biofilm infections with this model.

Learn more here

Get in Touch

We are happy to help with your microbiological requirements and with any other queries you may have.

Get in touch with us today

Perfectus Biomed

Perfectus Biomed, a UKAS accredited microbiological contract testing company, represents the new wave of scientific businesses that are proud to call Daresbury home.

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