{"product_id":"mpack-self-sealing-sterilization-pouches-class-4-dual-indicator-200-per-box","title":"MPACK Self-Sealing Sterilization Pouches — Class 4 Dual Indicator, 200 per Box","description":"\u003cp\u003e\u003cstrong\u003eSelf-sealing sterilization pouches with Class 4 internal and external process indicators\u003c\/strong\u003e, 200 pouches per box. Suitable for steam autoclave (121 °C \/ 134 °C) and ethylene oxide (EO) sterilization.\u003c\/p\u003e\n\n\u003ch2\u003eWhat does this pouch do?\u003c\/h2\u003e\n\u003cp\u003eIt is a sterile barrier system with its own process monitoring built in. Each pouch carries two chemical indicators: an external indicator strip printed on the paper face, and an internal Class 4 indicator printed inside the pouch. Both change colour only when the sterilization parameters have been met, so a pouch that never reached temperature stays visibly unconverted and never reaches the shelf.\u003c\/p\u003e\n\u003cp\u003eThe intended use is the one the packaging standard describes: hold a cleaned and dried instrument set sterile from the end of the cycle to the point of use. The paper face is the sterile barrier that lets steam in and keeps microorganisms out; the film face keeps the contents dry and visible. Neither indicator proves sterility — that claim belongs to the biological indicator, run on the schedule your province sets.\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eClass 4 dual indicator\u003c\/strong\u003e — an internal indicator and an external indicator strip on every pouch. Both change colour only when the sterilization parameters have actually been met, so a pouch that never reached temperature stays visibly unconverted.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSelf-sealing\u003c\/strong\u003e — fold-over adhesive strip, no heat sealer required. A perforated fold line keeps the pouch closed and gives a clean peel.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWrite-on area\u003c\/strong\u003e — each pouch carries a blank field for contents, date and operator.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e60 gsm medical-grade paper + 52 µm CPP\/PET film\u003c\/strong\u003e — the paper side lets steam and EO through; the film side keeps the contents sterile after the cycle.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2\u003eWhat sizes are available, and which size fits which instrument set?\u003c\/h2\u003e\n\u003cp\u003eSeven sizes, all 200 pouches per box, all stated as usable interior width × length. Choose the smallest pouch that holds the set without the instruments touching the seal line, because a pouch that is over-filled closes on itself and blocks steam from reaching the folds.\u003c\/p\u003e\n\u003ctable\u003e\n\u003cthead\u003e\u003ctr\u003e\n\u003cth\u003eSize (usable width × length)\u003c\/th\u003e\n\u003cth\u003eMetric\u003c\/th\u003e\n\u003cth\u003ePouches per box\u003c\/th\u003e\n\u003c\/tr\u003e\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003e2.5″ × 4″\u003c\/td\u003e\n\u003ctd\u003e57 × 130 mm\u003c\/td\u003e\n\u003ctd\u003e200\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e2.75″ × 9″\u003c\/td\u003e\n\u003ctd\u003e70 × 260 mm\u003c\/td\u003e\n\u003ctd\u003e200\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e3.5″ × 5.25″\u003c\/td\u003e\n\u003ctd\u003e90 × 165 mm\u003c\/td\u003e\n\u003ctd\u003e200\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e3.5″ × 9″\u003c\/td\u003e\n\u003ctd\u003e90 × 260 mm\u003c\/td\u003e\n\u003ctd\u003e200\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e5.25″ × 10″\u003c\/td\u003e\n\u003ctd\u003e135 × 283 mm\u003c\/td\u003e\n\u003ctd\u003e200\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e7″ × 13″\u003c\/td\u003e\n\u003ctd\u003e190 × 360 mm\u003c\/td\u003e\n\u003ctd\u003e200\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003e10″ × 15″\u003c\/td\u003e\n\u003ctd\u003e230 × 408 mm\u003c\/td\u003e\n\u003ctd\u003e200\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003cp\u003e\u003cem\u003eSize stated is the usable interior width × length. The sealed flap adds roughly 30 mm to the overall length.\u003c\/em\u003e\u003c\/p\u003e\n\u003cp\u003eThe selection rule that survives a busy week: measure the longest instrument, add the fold and the seal, and take the next size up rather than the size that only just fits.\u003c\/p\u003e\n\u003ctable\u003e\n\u003cthead\u003e\u003ctr\u003e\n\u003cth\u003eWhat goes in the pouch\u003c\/th\u003e\n\u003cth\u003eRecommended size\u003c\/th\u003e\n\u003cth\u003eWhy this size\u003c\/th\u003e\n\u003c\/tr\u003e\u003c\/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd\u003eBurs, endodontic files, sutures, a single mirror\u003c\/td\u003e\n\u003ctd\u003e2.5″ × 4″ (57 × 130 mm)\u003c\/td\u003e\n\u003ctd\u003eShort single items; the pouch stays flat under a full load\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eOne long hand instrument, a probe, a scaler tip\u003c\/td\u003e\n\u003ctd\u003e2.75″ × 9″ (70 × 260 mm)\u003c\/td\u003e\n\u003ctd\u003eLength without wasting width\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eTwo to three hand instruments, scissors, curettes\u003c\/td\u003e\n\u003ctd\u003e3.5″ × 5.25″ (90 × 165 mm)\u003c\/td\u003e\n\u003ctd\u003eEnough width for instruments to lie side by side, not stacked\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eOne dental handpiece, an air\/water syringe, an ultrasonic tip set\u003c\/td\u003e\n\u003ctd\u003e3.5″ × 9″ (90 × 260 mm)\u003c\/td\u003e\n\u003ctd\u003eHandpiece length plus room at the seal line\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eBasic examination set, small dressing pack\u003c\/td\u003e\n\u003ctd\u003e5.25″ × 10″ (135 × 283 mm)\u003c\/td\u003e\n\u003ctd\u003eFour to six instruments with space between them\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eFull procedure set, several cassettes' worth of instruments\u003c\/td\u003e\n\u003ctd\u003e7″ × 13″ (190 × 360 mm)\u003c\/td\u003e\n\u003ctd\u003eKeeps the set shallow so steam reaches the middle\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eLarge trays, bulky or textile items, orthodontic pliers sets\u003c\/td\u003e\n\u003ctd\u003e10″ × 15″ (230 × 408 mm)\u003c\/td\u003e\n\u003ctd\u003eThe largest format; the pack still has to remain flat\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\n\u003ch2\u003eWhen should I use a self-sealing pouch instead of a roll or wrap?\u003c\/h2\u003e\n\u003cp\u003eUse a pouch when the pack has a predictable size and you want the indicators already inside it: the pouch is the package and the internal Type 4 indicator in one step, with no sealer, no tape and no second label. Use a roll or sheet when the pack is longer or wider than any stocked pouch, when the set is heavy enough to need a two-layer wrap, or when the item has sharp edges that would puncture film.\u003c\/p\u003e\n\u003cp\u003ePublic Health Ontario's provincial reprocessing guidance requires an internal chemical indicator inside every package, placed in the area judged least accessible to the sterilizing agent; a printed internal indicator satisfies that requirement without a further consumable. That is the practical argument for pouches in a dental operatory: the compliance step is already inside the package.\u003c\/p\u003e\n\u003cp\u003ePouches are the wrong choice for a heavy cassette that will be handled repeatedly, and they are the wrong choice for an item that must be presented on a wrapped tray in the treatment room. The \u003ca href=\"\/fr\/collections\/sterilization-pouches\"\u003eClass 4 self-sealing pouch range\u003c\/a\u003e covers everything between those two ends.\u003c\/p\u003e\n\n\u003ch2\u003eWhat are the common sealing and loading errors that invalidate sterilization?\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eOver-filling.\u003c\/strong\u003e Instruments pressed against the film create tension that opens the seal in the sterilizer, and a pouch that bulges cannot lie flat in the tray.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSealing over a crease or over the indicator.\u003c\/strong\u003e The adhesive strip needs a clean, dry, flat surface; a fold in the paper under the strip leaves a channel.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWriting on the film instead of the write-on area.\u003c\/strong\u003e Marker on the film can be wiped off, and a pouch that cannot be traced to a load is not traceable after a recall.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLoading face to face.\u003c\/strong\u003e Paper faces should face the same way, standing on edge and loosely packed, so steam and air can move between pouches.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRe-processing a pouch that was opened and not used.\u003c\/strong\u003e A pouch whose seal has been opened is no longer a sterile barrier; it is repackaged, not resealed.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eStoring a warm pouch in a closed drawer.\u003c\/strong\u003e Condensation forms inside the film and wets the paper — the pack is then compromised even though the indicators changed.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReading the external strip only.\u003c\/strong\u003e The external indicator shows exposure; the internal Class 4 indicator is the one printed at the point judged least accessible to steam.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2\u003eWhat standards does it meet?\u003c\/h2\u003e\n\u003cp\u003eManufactured to \u003ca href=\"https:\/\/www.genorma.com\/en\/standards\/iso-11607-1-2019\"\u003eISO 11607-1:2019\u003c\/a\u003e (packaging for terminally sterilized medical devices — materials, sterile barrier systems and packaging systems; second edition, published 31 January 2019 and confirmed in July 2024), and to the EN 868 series for packaging materials. The indicators are Class 4 chemical indicators under \u003ca href=\"https:\/\/www.iso.org\/standard\/55080.html\"\u003eISO 11140-1:2014\u003c\/a\u003e, which is the standard that defines what a chemical indicator is, the six classes, and the test methods behind them; Class 4 means an indicator that responds to two or more critical variables rather than to temperature alone. Made in China.\u003c\/p\u003e\n\u003cp\u003eThe pouch itself is cleared by the manufacturer under FDA 510(k) K071886. Canadian reprocessing practice for the clinic using it is set by \u003ca href=\"https:\/\/store.csastandards.org\/store\/product\/2430344\/\"\u003eCSA Z314:23\u003c\/a\u003e, the current edition of the national sterilization standard, applied in Ontario through Public Health Ontario's \u003ca href=\"https:\/\/www.publichealthontario.ca\/-\/media\/Documents\/B\/2013\/bp-cleaning-disinfection-sterilization-hcs.pdf\"\u003ePIDAC-IPC guidance\u003c\/a\u003e.\u003c\/p\u003e\n\n\u003ch2\u003eHow should these pouches be stored?\u003c\/h2\u003e\n\u003cp\u003eIn a clean, dry, dust-free area, on closed shelving, off the floor, away from window sills and sinks, and away from direct sunlight. Canadian guidance for sterile storage gives the environmental envelope: temperature maintained between 18 and 23 °C and relative humidity between 30% and 60%, with humidity monitored — the same PIDAC-IPC section notes that humidity above 70% can leave packages damp enough to require reprocessing.\u003c\/p\u003e\n\u003cp\u003eShelf life is event-related rather than time-related in that guidance: a pouch that has been correctly processed, stored and handled remains sterile until its integrity is compromised — opened, wet, torn, punctured or crushed. So the date on the pouch is a traceability element, not a countdown, and the practical rule is to inspect the pack before use and reprocess anything that is damp, damaged or unlabelled. Pouches can stay in their dispenser box until use, but that carton is not a storage container: Public Health Ontario requires storage containers to be moisture-resistant and cleanable, and states that cardboard boxes must not be used. Do not use if the pouch is damaged or the seal has been opened, and do not re-use it.\u003c\/p\u003e\n\n\u003chr\u003e\n\n\u003ch2\u003eWho manufactures and distributes it?\u003c\/h2\u003e\n\u003cp\u003e\u003cstrong\u003eManufactured by\u003c\/strong\u003e\u003cbr\u003e\nShanghai Jianzhong Medical Packaging Co., Ltd.\u003cbr\u003e\nBldg 16, #789 Puxing Road, Minhang District, Shanghai 201114, China\u003cbr\u003e\nFDA 510(k) K071886 · FDA Establishment Registration on file\u003c\/p\u003e\n\n\u003cp\u003e\u003cstrong\u003eDistributed by\u003c\/strong\u003e\u003cbr\u003e\nCliniEco Medical — Ecology Source New Energy Technology Co., Ltd.\u003cbr\u003e\n255 Duncan Mill Road, Suite 512, Toronto, ON M3B 3H9, Canada\u003cbr\u003e\nCanadian MDEL #35334\u003c\/p\u003e\n\n\u003cp\u003e\u003cem\u003eCliniEco Medical distributes this product as an authorised distributor. The product is manufactured and labelled by Shanghai Jianzhong Medical Packaging Co., Ltd.; the 510(k) clearance and FDA establishment registration are held by the manufacturer.\u003c\/em\u003e\u003c\/p\u003e\n\n\u003cp\u003eFor clinics that buy by the case and need the load record to match the packaging, the \u003ca href=\"\/fr\/collections\/sterilization-monitoring\"\u003eautoclave monitoring and spore testing range\u003c\/a\u003e sits alongside this product, and the \u003ca href=\"https:\/\/clinieco.ca\/pages\/compliance-log-center\"\u003ecompliance log centre\u003c\/a\u003e carries the printable load sheets those records go on.\u003c\/p\u003e\n","brand":"MPACK","offers":[{"title":"2.5\" x 4\" (57 x 130mm)","offer_id":49431207739614,"sku":"MPACK-SP-57130","price":5.49,"currency_code":"CAD","in_stock":true},{"title":"2.75\" x 9\" (70 x 260mm)","offer_id":49431207772382,"sku":"MPACK-SP-70260","price":8.99,"currency_code":"CAD","in_stock":true},{"title":"3.5\" x 5.25\" (90 x 165mm)","offer_id":49431207805150,"sku":"MPACK-SP-90165","price":8.99,"currency_code":"CAD","in_stock":true},{"title":"3.5\" x 9\" (90 x 260mm)","offer_id":49431207837918,"sku":"MPACK-SP-90260","price":10.99,"currency_code":"CAD","in_stock":true},{"title":"5.25\" x 10\" (135 x 283mm)","offer_id":49431207870686,"sku":"MPACK-SP-135283","price":16.99,"currency_code":"CAD","in_stock":true},{"title":"7\" x 13\" (190 x 360mm)","offer_id":49431207903454,"sku":"MPACK-SP-190360","price":25.99,"currency_code":"CAD","in_stock":true},{"title":"10\" x 15\" (230 x 408mm)","offer_id":49431207936222,"sku":"MPACK-SP-230408","price":32.99,"currency_code":"CAD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0797\/5741\/0526\/files\/274882b3bf725b62d8dfd171d8fa96d6_4f54eaaa-e062-4fb8-9497-80243f378789.webp?v=1794535485","url":"https:\/\/clinieco.ca\/fr\/products\/mpack-self-sealing-sterilization-pouches-class-4-dual-indicator-200-per-box","provider":"CliniEco Medical","version":"1.0","type":"link"}