ABSTRACT
Two types of Tyvek and high density polyethylene or polypropylene packaging used for sterilization of rubber closures were evaluated for Microbial Barrier properties. The packaging evaluated was "Ready to Sterilize" (1) stoppers and a second test package (Test 2) which was designated as appropriate for a clean room, filled with washed and siliconized stoppers and then heat sealed. Each type of packaging was subjected to three different sterilization temperatures (125 degrees C, 128 degrees C and 131 degrees C) in a production sterilizer (15-18 psi). Following sterilization, a microbial barrier assessment was performed, using Bacillus subtilis niger (ATCC 9372), to determine whether the packaging could maintain a sterile barrier following sterilization. Results of the testing indicated that a microbial barrier was maintained for products in "Ready to Sterilize" packages at 125 degrees C and 128 degrees C. For products sterilized in the Test 2 container a microbial barrier could not be maintained at 128 degrees C, and no further testing was performed. Following sterilization at 131 degrees C physical defects were noted for the "Ready to Sterilize" bag and a microbial barrier could not be maintained.
Subject(s)
Drug Contamination/prevention & control , Drug Packaging/standards , Materials Testing , Polymers , Rubber , Sterilization/methods , Bacillus subtilis/isolation & purification , Evaluation Studies as Topic , Illinois , Spores , United States , United States Food and Drug AdministrationABSTRACT
Three frequently used strains of Bacillus were tested using antimicrobial susceptibility test discs to determine their resistance to various antimicrobial drug agents. The organisms selected were B. subtilis ATCC 6633 (used for USP B and F tests), B. stearothermophilus ATCC 12980 (used as a biological indicator for steam sterilization) and B. coagulans ATCC 51232 (used as a biological indicator for steam sterilization). The results indicated that for the thirty antimicrobial drug agents tested, the only organisms which exhibited any resistance to these agents was B. subtilis, and it only showed resistance to two drugs (Aztreonam and Bacitracin).
Subject(s)
Bacillus/drug effects , Drug Resistance, Microbial , Microbial Sensitivity TestsABSTRACT
Bacillus coagulans, ATCC 51232 (formerly referred to as FRR B666), was previously reported to be a potentially excellent biological indicator. The organism was grown on a relatively simple sporulation media and the spores were evaluated for moist heat resistance in various parenteral solutions. Resistance was determined using the survivor curve method. For those solutions which appeared to be inhibitory to the outgrowth of Bacillus coagulans, ATCC 51232, further investigations were performed to evaluate the inhibitory effect. The results obtained demonstrated that the organism had the highest resistance in Calcium Gluconate Injection; USP (100 mg/mL) at 120 degrees C.
Subject(s)
Bacillus/physiology , Hot Temperature , Sterilization/standards , Bacillus/growth & development , Culture Media , Drug Contamination , Environment, Controlled , Infusions, Parenteral , Solutions , Spores, Bacterial/growth & development , UltrafiltrationABSTRACT
Bacillus stearothermophilus spores (liquid suspension) were inoculated onto rubber stoppers and exposed to sublethal steam sterilization cycles at 120 degrees C. The D-values were determined using the fraction-negative method. An increase in heat resistance (D-value) of 200%-400% was observed when the spore suspension was inoculated onto rubber stoppers. The D-values ranged from 4.90-6.96 minutes 120 degrees C. No significant effect was seen when different preservatives were added to the stoppers nor when hot or cold rinse water temperatures were used after processing.
Subject(s)
Geobacillus stearothermophilus/physiology , Preservatives, Pharmaceutical/pharmacology , Sterilization , Drug Packaging , Geobacillus stearothermophilus/drug effects , Rubber , Spores, Bacterial , TemperatureABSTRACT
In an industrial application, biological indicator test units can often remain at room temperature for several hours prior to a steam sterilization validation cycle. A study was performed using the biological indicator Bacillus coagulans suspended in 10% Calcium Gluconate, USP, to determine if room temperature hold time had an effect on the resistance of the biological indicator. The results indicated that no significant change in resistance was seen for hold times up to 24 hours at room temperature.
