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 and can be inoculated with any organism we manufacture. Several types and sizes of discs are available including: paper, borosilicate paper, and stainless steel. The user must determine the suitability of the indicator for their particular use.
Omaha Manufacturing Facility (OMF) – located in Omaha, Nebraska
Primary Products – Spore Strips, ProTest, ProSpore Ampoule, Industrial Use BIs
Customer Service Contacts:
402.593.0781 or 800.728.5702
Bozeman Manufacturing Facility (BMF) – located in Bozeman, Montana
Primary Products – EZTest, Apex products, MagnaAmp, MesaStrip
Customer Service Contacts:
406.585.9535 or 877.746.8883
Steel discs (mm) are representative of materials found in an isolator, and are compatible with vapor hydrogen peroxide. We strongly recommend our polished stainless steel to eliminate crevices in the carrier which can lead to tailing.
Discs are packaged in a Tyvek/Tyvek® pouch; see Certificate of Analysis for resistance characteristics.
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) and radiation sterilization.
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 or with another organism. 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.
Steel Coupons (same size as our standard paper strip: Dimensions: 7mm x 32.8mm x 0.45mm) are intended for use in dry heat ovens at depyrogenation temperatures.
Inoculated with 106 B. atrophaeus spores, they are used to correlate spore death (sterilization) with endotoxin reduction. Mesa does not sell endotoxin or other LAL reagents at this time.
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 or with Geobacillus stearothermophilus.
microStrips are available in bulk (1,000 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 or purified water.