We provide biological safety evaluation of medical devices to determine the response from contact of the device, or component materials with the body. Such tests are essential to demonstrate the biological safety of the device or it's component materials.

Please note that for reasons of animal welfare, and in compliance with the conditions of our project licences issued by the UK Home Office, contract testing laboratories in the UK can now only proceed with testing of medical devices using animals if it is not possible to establish the safety of the product by non-animal methods.

This is fully in compliance with the strategies set forth in EN ISO 10993 and means that before any animal testing can proceed, we must consider whether the safety of the device(s) can be determined by one or more of the following means:

1) By comparison of the product to an existing commercially available device for which product safety data is already available.
2) By review of existing toxicological data for the individual constituents of the device
3) By the use of in vitro tests.

• Cytotoxicity:
  Cell culture techniques can provide a rapid and sensitive means of detecting adverse effects on cells i.e. cell death or inhibition of cell growth.
• Haemolysis:
  Determines the degree of red blood cell lysis and the release of haemoglobin in vitro.
• Irritation:
  Assesses the primary irritancy of materials intended for contact with the eye or skin.
• Sensitisation:
  Estimates the potential for contact sensitisation of devices, materials and/or their extracts. Exposure or contact to even minute amounts of potential leachables can result in allergic or sensitisation reactions.
• Intracutaneous Reactivity:
  Assess the localised reactions of tissue to device extracts. These tests are applicable where the determination of irritation by dermal or mucosal tests are inappropriate eg devices having access to blood path.
• Systemic Toxicity:
  Determines the harmful effects of either single or multiple exposures to materials and/or extracts.
  Pyrogen tests may be included to evaluate material mediated reactions.
• Implantation:
  Evaluates the local pathological effects on living tissue at both the gross level and microscopic level, to a material that is surgically implanted into an appropriate site eg. muscle.
• Genotoxicity:
  Bacterial mutagenicity assays and in vitro mammalian cell culture tests are used to determine the frequency of induced gene mutations and/or changes in chromosome structure.
  

• Sub-chronic Toxicity:
  Determines the harmful effects from multiple exposures of material and/or extracts during a period of up to 90 days.
• Chronic Toxicity:
  Determines the harmful effects from multiple exposures to test materials and/or extracts during a period of 10% of total life span (eg over 90 days in rats).
• Carcinogenicity:
  Determine the tumorigenic potential of devices, materials and/or their extracts from either a single or multiple exposures, over a period of the total life of the test animal. These tests may be designed in order to examine chronic toxicity and tumorigenicity in a single experiment. Carcinogenicity tests should be conducted only if there are suggestive data from other sources.
• Reproduction Toxicity:
  Evaluates the potential effects of devices, materials and/or extracts on reproductive function, embryonic development and prenatal and early postnatal development. Reproductive/Development toxicity tests should only be conducted when the device has potential impact on the reproductive system.
• Selection of Appropriate Tests:
  Our experts can provide advice on the selection of appropriate tests to ensure that the testing program conducted at SafePharm meets the necessary regulatory requirements.
  Our philosophy is to establish a good, strong and lasting relationship with the customer.Also to provide a high quality, flexible service whilst maintaining our position at the cutting edge of contract research laboratory service by providing rapid turnaround times and competitive prices.