BIOLOGICAL INDICATOR INSTRUCTIONS -- NAS-152 Certifi cate of Analysis PROCESS EVALUATION 'Place biological indicators in Iocations pleviously deterrnined to be the most diffrcult to sterilize. Aleas experiencing rninimal gas flow or poor gas distribution include enclosure comers, areas in and atouud equiptnent, and locations among disposable rnate¡ials to be used in the enclosure. Note that the inoculated side ofthe carrier faces the prìnted label on the Tyvek pouch, therefore the printed side should face outward during a process cycle. Apex Biological Indicator (Reorder # NAS-I52) for Gaseous Hydrogen Peroxide Lot #: N0975 02 Manufacfure: 2015 APRIL Expiration: 2016 JANUARY 31 Indicator: Geobacillus stearothermophilus 7953 (t) Mean population: àlij x 106 CFU per stainless steel carrier (2) Storage conditions: 2-8"C; less than 50% RH; move to ambient conditions > t hr before use. Shipping conditions: Ambient temperatures; cold pack and desiccant may be used to moderate conditions during shipping. Resistance Characteristics D-value(3): .Conduct the sterilization and aemtion cycle. 'Retnove the indicatols and deliver thern, plus one ol morc unexposed control indicators, to the labomtoly fol sterility testing. Culturing of exposed indicators should be conducted as soon as possible following rerroval from the enclosure being tested. CULTURING PROCEDURES 'Culture in a laminar flow hood. Observe shict aseptic technique at all times. Minirnally, sterile gloves should be wom. Include donning hoods, masks, and gowns as appropriate for the facility and : circumstances. 0.7r¡inutesin2rnglLgaseousHzOz 'Aseptically open the Tyvek pouch by cutting with sterile scissors or peeling apart at the end with the package offset. units are manufactured in cornpliance with Mesa Laboratory, Bozeman Manufacturing Facility's quality standards and ISo 1 I 138-1 guidelines and all appropriate subsections. 'l]sing sterile forceps, withdmw the canier and place in a tube containing sterile Soybean Casein Digest Mediurn (SCDM) / Tryptic Soy Broth (TSB). .Aseptically cultu¡e the control carrie(s) last. Purity: No evidence of contaminants using standard plate count techniques. Incubate at 55-60"C for 7 days. The recommended growth medium is Soybean Casein Digest Medium (SCDM) / Tryptic Soy Broth (TSB). .Select one or mole tubes ofthe sarne lot ofculture lnediurn to sewe as negative controls. .lncubate test and control tubes for 7 days at 55-60'C. Observe daily for evidence of growth (tuÌbidity). INTERPRETATION This product is for Industrial Use Only. Disposal: Treat 'Validation and napping processes generally lequire rnultiple indicators at numerous sites in an enclosure. .Turbidity: as non-pathogenic material and sterilize (steam, EtO, etc) or For test indicatom, tuúidity suggests that the stedlization was incomplete and that at least one incinerate before discarding. spore suwived the process. (r)Culture is traceable to a recognized culture collection identified in USP and ISO I I I 38. (2) Heat shock population detennined at 95-l 00"C for I 5 rninutes (3) Resistance was calculated using Fraction Negative rnethod. The D-value is leproducible only when exposed and cultured under the exact conditions used to obtain results reported here. Fol positive contrcl indicators, turbidity indicates that viable spores were present and capable of^outgrowth in the culture mediurn used. hr negative contlol tubes, turbidity indicates that viable organisrns rnay have been present in . the growth rnedium. Contact youl supplier. .No turbidity: _ Fol test indicators, lack ofturbidity indicates sterjlization was complete and no spores survived the process. hr negali.ve contlol tubes, Iack _ oftutbidity indicates no other viable organisms were present in . the culture medium. For positive control indicator, no turbidity suggests no viable organisrns were present on the canier or that the media tnay be inhibiting the outgrcwth of the test olganism. Contaòt your supplier. Certified By: ffi MesaLmhs Bozeman Mânufacturing Facility I 0 Evergreen Drive Bozeman, MT 59715 T: 303/987-8000 ¡ F: 406/585-9219 www.mesalabs.com Rev. I 23MAR201 5 Part #: 36.7008-1 0 LIMITATION OF LIABILITY AND INDEMMTY: h ilo evqn, whdhs as r r6ulr of brøch of øntrad, wirmty or lor (inctuding n()[email protected]@ rd srict liabilily) slall M6a LabE or ils suppl¡m be liable for ary onsequør¡al or incidmral dâmag6 inchding, btrl nol linúted tò Ios ofprofils oriaouq los ofuse of ürc PrfilLtcls or my aswialql cquiÞmsn, loss of tl¡c Bilys's Prodncts, damagc lo ñ@i¿lqt cquipmøt, 6st of øpilal, ø$;f $bsitutc product$ fâcilitiG, swiæ or rq)låænìqrl powq domtiûe @sl, øusql by such Prodrcts, or claims of lhe rs6 for such dilrage. Buyaior itsclf, its s(rcoß ûd Nignq hsóy ag¡6loi¡ldemlifyM6¡lábstldloholdM6aljbshmil6sliomûrydrdållliabilityforsuchmnscquoitialorincidstâldåmgs. 1-Ïer6lþnsibilityófM6; láh6 fordmags due lo iliüi6lo @ploy6 of lhe Btryq or ulliDðtcrßs of the Muc¡, øuscd by thc Product, sltall bc limiluiro rqrair orrqtlaøul of tle ilmlddleopliorofM6abbs. Th€Buyqagr6loilrdmifyM6aljbsddhotdM6ahbshmlslÌomðtynflhqdamgeqirrdmityorørtiburion. M6a ljb6 liab¡lily for oty claim of ury kirrd, includirg pslòmeìæ or brqcjì ü[email protected] o¡ Êonì lhe Products Io Swi6 Amish€d h6mdq;sltall in no 6e qc€€d thepriæ oflhc speifiql Product, slsm, @mpoDoil o¡ [email protected]æ wbich giv6 risc to dleclâiû.
© Copyright 2018