Standard Biological Indicators (BIs) are easy to use and are available for industrial or healthcare use. However, some manufacturing situations require a modified or specialty Biological Indicator to assist in validating the sterilization process. Manufacturers and validation specialists require unique tools where spore strips and ampoules are not suitable because of size, packaging or carrier material. Mesa offers a full line of Industrial Use BIs to address the unique requirements of the medical device and pharmaceutical industries.
Discs have advantages over spore strips due to their size. Different materials may be compatible only with specific modes of sterilization. Discs can be used to monitor various sterilization methods. Several types and sizes of discs are available. The user must determine the suitability of the indicator for their particular use.
Paper discs (6mm and 9mm) have been used to validate sterilization of contact lenses in steam where placement of a strip was impossible due to its size. They are also suitable for EO, Dry Heat (up to 180°C).
Woven Cotton Threads
Threads (Length: 19mm Diameter: 1.5mm) have been used at the interface of a syringe and plunger to show sterilant penetration and efficacy at that point. Other uses include placement in tubing and small vials. Bio-threads are 100% cotton, 3/4″ long, and are inoculated with B. atrophaeus. The device/lumen into which the thread is inserted affects its resistance characteristics.
A polyester suture (Size: Length: 5cm, Diameter: 0.15mm) is desirable in situations where more flexibility and a small diameter is necessary. Polyester sutures are easy to handle and can be wrapped around or inside objects to aid in sterilization validation of a variety of situations and products.
ProLine (Tubing Validation PCD)
Biological Indicator system designed for use in the validation or monitoring of steam sterilization cycles of tubing ranging from 1/8″ to 5/8″ tubing ID. The ProLine PCD (Process Challenge Device) contains a filter paper disc inoculated with bacterial spores of Geobacillus stearothermophilus.
Standard spore strips are 38mm X 6mm (1 ½ X ¼ inches) making them difficult to use in lumens or other small area. At 2mm X 10mm or 1mm x 25mm, microStrips can be used in areas where other BI’s are too large. Mesa’s microStrips are available inoculated with Bacillus atrophaeus, Bacillus subtilis 5230, or with Geobacillus stearothermophilus.
microStrips are available in bulk (100 units) or packaged in glassine envelopes (100 units).
Mesa spore suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of products or preparing custom biological indicators for monitoring steam, ethylene oxide, dry heat, hydrogen peroxide, radiation, and other industrial sterilization processes. Each vial contains 10ml of suspension. The suspending liquid is 40% ethanol.