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.The user must determine the suitability of the indicator for their particular use.
Paper discs (6mm) 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.
Stainless Steel Coupon
Stainless Steel Coupons (33.0mm x 7.2mm) inoculated with 106 B. atrophaeus spores are designed for use in high temperature dry heat applications where paper strips are not appropriate or where a stainless steel surrogate is desired.
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).
Stainless Steel Disc
The Stainless Steel Disc (7mm) is inoculated with 103 or 106 B. pumilus spores and packaged in clear plastic. The clear plastic package will not impede UV light and provides protection from post-process contamination.