Services

Microbiological Analysis

Microbial assays involve a variety of tests, from the determination of the numbers and types of organisms naturally present on a product to the assessment of controlled environments. With our comprehensive menu of microbiology services, the Medical Device Testing division provides services across the product development lifecycle and beyond, from R&D and screening to in-process release, validation, and finished product delivery.

• Product Sterility

  Product sterility testing is typically performed in the validation of sterilization processes and, in some cases, for monitoring sterilization cycles. Sterility tests involve total immersion, membrane filtration, or a rinse method. The number of samples tested, the growth medium used, and the incubation conditions are based on the particular standard involved - USP/ISO.

  • Sterility Immersion

    This test is used in sterilization validations (e.g., radiation, EO) and to monitor sterilization loads. This test follows USP and ISO standards.

  • Sterility Membrane Filtration

    This test is used in sterilization validations (e.g., radiation, EO) and to monitor sterilization loads. This test follows USP and ISO standards.

• Bioburden

  Bioburden testing is an assessment of the numbers and types of microorganisms present on a product and is used for assessment of incoming materials, indication of manufacturing conditions, and support of sterilization validations.

  • Aerobic Bioburden

    Aerobic count

  • Fungal Bioburden

    Mold and yeast counts

  • Spore Bioburden

    Aerobic spore count

  • Anaerobic Bioburden

    Anaerobic count

    Aerobic spore count

  • Total Bioburden Panel Aerobe / Anaerobe / Spore / Fungi

    Intended for items for which a full characterization of the bioburden is needed. Additional combined bioburden testing is available.

• Bacterial Endotoxin

  Bacterial Endotoxin test (BET) is a test to detect or quantify endotoxins from Gram- negative bacteria using amoebocyte lysate from the horseshoe crab ( Limulus polyphemus or Tachypleus tridentatus ).

  • Endotoxin Testing - UGel-clot technique - USP

    This test is performed by Gel-clot technique on medical devices according to USP.

  • Endotoxin Testing - Kinetic Chromogenic techniques - USP

    This test is performed by Kinetic Chromogenic techniques on medical devices according to USP.

• Sterilization validation

  A radiation validation determines the appropiate radiation sterilization dose for a medical device that requires a sterile label claim.
  The most common validation methods are VDmax (verification dose maximum) and Method 1. Both methods are available in a single batch validation or a full 3-batch validation.

  • Method 1

    "Using Bioburden Information" Information must be obtained regarding the number of the micro-organisms on or in a product. This is then compared to a standard distribution of resistances (SDR) to determine the minimum sterilization dose. The Bioburden level will lead to a certain irradiation dose.

  • VDmax25 or VDmax15 Method

    "Substantiation of 25 or 15 kGy" This method describes the selection of the minimum sterilization dose of 25 kGy. Laboratory testing is used to demonstrate that a SAL 10-6 has been achieved with the selected minimum sterilization dose. The limit on allowable numbers of bioburden is 1,000 cfu per product unit for the VDmax25 and 1.5 cfu per product for the Vdmax15.

If you have additional questions about the test, or would like to consult with the experts at Biolink, ASK OUR EXPERT