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All Namsa products require minimal user training, are manufactured in ISO 13485 certified facilities and meet domestic and international standards
Biological Indicators Strips and Discs
All spore strips are packaged in glassine envelopes. Discs are packaged in bulk without glassine envelopes in shelf packs of 100. Most species are available in populations from 104 to 107 (other populations are available upon request*). NAMSA's SPORTROL Spore Suspensions are pure suspensions of viable spores for specific organisms of known resistance to various sterilization processes. They are suspended in water for injection and provided in 10 mL pharmaceutical vials. Most species are available in populations of 103 to 108 spores per 0.1 mL (other populations are available upon request*).
Technical Specifications for Spore Strips and Suspensions (18-month shelf-life) (Strips denoted by Code STX, Suspensions denoted by Code SUX)
Steam BI Data Sheet, Geobacillus stearothermophilus: Strips (STS) or Suspensions (SUS) Radiation BI Data Sheet, Bacillus pumilus: Strips (STP) or Suspensions (SUP) Dry Heat/EtO BI Data Sheet, Bacillus atropheus: Strips (STN) or Suspensions (SUN) Dry Heat/EtO BI Data Sheet, Bacillus subtilis: Suspensions (SBS) For the BI strips, Spores are inoculated on paper strips, packaged in individual glassine envelopes in packages of 100. We can also accommodate your specific needs by supplying strips in bulk without glassine envelopes (STX-062B) *Other populations available upon request. ** Smaller-sized spore strip (2mm x 10 mm). Standard size is approximately 6 mm x 30 firm. Spore Discs, Combination Spore Strips and Graded Population Test Kits*(18-month shelf-life)
Spores are inoculated onto paper discs, either 1/4-inch or 1/8-inch in diameter, packaged in bulk without glassine envelopes Custom Biological Indicators NAMSA can manufacture customize BI strips eg. Wire or thread BI’s, discs and other configurations to meet your specifications or private label production. We also can provide biological indicators with alternative organisms and populations. Namsa Spore Ampoules Namsa offers Geobacillus stearothermophilus spore ampoules for use in steam sterilization processes which are ideal for use in validation of liquid and non liquid sterilization cycles. No activation is required; simply expose to sterilization process and incubate. For further information, click on the following; Namsa Self-Contained BI’sNAMSA offers Self-Contained Biological Indicators (SCBI) for monitoring steam (spore population = 105 and 106) and Ethylene Oxide (population 106) sterilization processes. Each SCBI unit consists of a plastic container with a cap, a crushable glass ampoule with recovery media, and a paper disc inoculated with spores. NAMSA SCBIs are offered in boxes of 50 units. SCBIs are certified for species, population, purity, resistance (dvalue, z-value, where applicable) and expiration date. SCS-05 Geobacillus stearothermophilus (Steam)
Only minimal training is required to use SPORTROL Biological Indicators. For Namsa Test Methods or Material Safety Data Sheets please contact info@mactec.ie where we can supply you with the following information;
Alternatively, processed or exposed biological indicators may be returned to NAMSA for testing.
Chemical Indicators NAMSA's Chemical Process Indicators are self-adhesive labels suitable for application by hand or Meto gun on shipping cartons or individual packages. The label color indicates at a glance whether or not the product has gone through the sterilization process, making it easy for sterilization facilities and manufacturers to control inventory and assure end users that products have been exposed to the sterilization process. Storage Considerations - All Indicator Types Short-term, moderate heat (up to 35°C) or humid environmental conditions will not adversely affect the indicators' unexposed color. Storage in a cool, dry place at room temperature is recommended. Indicators should not be exposed to prolonged UV light, direct or indirect sunlight. After exposure to the sterilization process, NAMSA Chemical Process Indicators are stable. For information on Gamma radiation labels, EtO, steam or vapour hydrogen peroxide chemical indicator labels. Custom Labels Custom indicator labels are a convenient, cost-effective option for manufacturers who wish to combine a sterilization indicator with an existing label. These custom indicators can be any size or shape, in roll or sheet formats, and are designed for application directly to an existing label, pouch, carton, or other container as required. NAMSA currently manufactures custom labels for leading companies in the medical device, garments, food and packaging industries. Contact NAMSA for more information or a price quote on custom label configurations. Sterilization Process Indicator inks Flexographic/Gravure Inks can be used on labels, strips, films, papers, pouches, tapes and lid stock materials to monitor exposure to ethylene oxide, steam, hydrogen peroxide, dry heat, chemiclave, steam-formaldehyde and combination EO/steam. Silkscreen inks for steam are also available. To obtain pricing and further information on the Namsa Range of Products please contact info@mactec.ie.
Growth Promotion Suspensions Growth Promotion Test Suspensions provide a quality control challenge to each batch or lot of medium, ensuring its growth promoting qualities, whether it is prepared from basic ingredients or purchased commercially prepared. Simply inoculate each batch or lot of medium and incubate under the appropriate growth conditions. Visible growth after incubation indicates the culture media is conducive to organism growth. Product Specifications and Applications NAMSA Growth Promotion Test Suspensions are ready-to-use microbial suspensions that meet the United States Pharmacopeia (USP) requirements for media performance testing. All suspensions comply with the USP <71> requirement for a population of <100 colony forming units (CFU) and are guaranteed to be within five passages of an original ATCC stock culture. All Growth Promotion Test Suspensions are provided as pure cultures in 2.5ml or 10 ml vials containing 25 or 100 doses (0.1ml each). For More Information on the Growth Promotion Suspensions, click on the following;
To obtain pricing and further information on the Namsa Range of Products please contact info@mactec.ie. SPS Medical
Packaging ProductsSPS Medical offers a complete line of sterile packaging for use with Steam, EO gas, Chemical vapor and Dry heat processes. FDA and ADA approved, we manufacture with heavy gauge medical grade paper and 2 mil clear poly film for the highest quality. Independent Lab Study documents sterilization performanc. Pouches and TubingQuality manufactured for a clean, fiber-free opening, SPS Medical pouches are FDA and ADA approved for use with Steam, EO gas and Chemical vapor processes. Color change CI's are printed paper side (under the plastic film) for exposure to the same sterilization conditions as the packaged item(s). Heat-Seal PackagingSPS Medical Heat-Seal Pouches can be mechanically sealed or manually sealed with autoclave tape.SPS Medical paper/poly tubing is manufactured to the same quality standards as our pouches and is stocked in 100 ft. Nylon PackagingSPS Medical nylon packaging, for use in high temperature dry heat, is available in both Self-Seal pouches and Roll Stock tubing. For use with loose instruments or cassettes, the material is clear and has a melt point of 420ºF. Tyvek PackagingManufactured with DuPont's spun bonded olefin and Mylar, SPS Medical Tyvek pouches provide a combination of physical characteristics for superior sterile packaging protection. Five (5) year shelf-life testing, barrier and sterilization performance data provided by DuPont's Haskell Laboratory.Manufactured to the same performance standards as our pouches, SPS Medical Tyvek tubing is designed to be cut to any length prior to packaging and then mechanically sealed or taped closed. Pouches and Tubing – AccessoriesCompact and easy to operate, each heat-sealer comes with setting instructions for all SPSMedical pouch, tubing and dust cover products. 1 year warranty.The SteriCoil® Pouch Divider is manufactured with 316 stainless steel, this simple and inexpensive device prevents overstacking and facilitates drying of pouches after processing (3" x 3" x 15"). The pouches and tubing come with a five year shelf-life and in a variety of sizes to suit individual needs. Customised product can also be produced to meet end-user specifications. For further information please click on the following;
Sterilisation PackagingSPSmedical offers a wide selection of disposable CSR Wrap and Sterility Maintenance Bags. Indicator tapes are available for most common sterilization processes, along with a proprietary LoopPlus® Banding System designed to eliminate adhesive tape problems and save money for facilities doing large volume packaging. Disposable WrapBlue nonwoven CSR wrap can be used for packaging instrument trays and materials. Use with Steam, EO gas, Chemical vapor or Radiation sterilization. Independent Lab Report documents how this product offers an excellent barrier to airborne bacteria, repellency to water, OR fluids and alcohol when compared to reusable muslin wraps. Made of natural fiber-based materials (i.e. wood pulp), each sheet is biodegradable and does not emit odors, toxic waste or other residues when incinerated. Excellent product for use with table-top sterilizers which can have temperature spikes. Indicator TapesIndividually packaged, our multiparameter autoclave tape can be used with disposable or reusable wrappers. Available in 3 widths for Steam and 3/4" width for EO gas, Dry heat or Chemical vapor processes. Sterility Maintenance BagsSelf-seal and Heat-seal Dust Covers are for use as a "sterility maintenance" bag after packs have been processed and properly cooled. Strong 3 mil polyolifin plastic protects against dust, moisture and airborne contaminants. Each SPSmedical Dust Cover is clear in design to provide 100% visibility of packs. Low-slip, polyolifin plastic material minimizes sliding during sterile storage. Built in "linear tear" feature makes opening each Dust Cover a simple task. LoopPlus System®This "new technology" banding machine is designed to secure packs before, during and after sterilization. Using a patented design, the LoopPlus banding machine automatically tensions, seals and cuts a LoopStrap around a pack in seconds, thus eliminating the need for autoclave tape. Increase worker productivity, save money and eliminate autoclave tape "adhesive damage" that can occur with reusable wrappers. LoopStrap is 1/4" x 2,500 ft. (762 meters) per roll.For product profiles on the items listed above, please click on any of the following; To obtain pricing and further information on the Namsa Range of Products please contact info@mactec.ie Biological IndicatorsSPSmedical offers the industry's most complete line of spore tests designed to meet the AAMI, USP and Mil Standards. Each BI contains live Bacillus spores, which document through their death that sterilization was actually achieved. Routine spore testing (at least weekly) is recommended and/or required by most healthcare agencies.Special Note: 24 hour read-out for all Steam cycles with mail-in spore tests. SporView® Self-Contained BI’sSelf-contained in-office biological indicator (BI) systems certified and available for saturated Steam or EO gas sterilization processes. After processing in a normal load, the user activates the media vial then incubates at 60ºC (Steam) for 24 hours or 37ºC (EO gas) for 48 hours. A color change in the media of a processed BI indicates sterilizer failure. The SporView® Plus System is an in-office Biological Indicator (BI) monitoring system with immediate read-out, for use in all Steam sterilization processes. Each box contains 25 SporView self-contained BI spore tests and 25 STEAMPlus Integrators that has been certified to perform equal to a BI plus a safety factory. The SporView® Culture Set is an in-office Biological Indicator (BI) system certified for use with Steam, EO gas, Chemical vapor and Dry heat. After processing in a normal load, the user aseptically transfers the BI strip into media and incubates at 56ºC (Steam/C-vapor) or 37ºC (EO gas/Dry heat) for 7 days. A color change and visible turbidity of a processed BI indicates sterilizer failure. Spore Ampule® Steam BIAn error-free, in-office BI system certified for use with saturated Steam sterilization processes including liquids. After processing in a normal load, the SporAmpule is incubated at 56ºC for 48 hours. A purple to yellow color change and visible turbidity of a processed SporAmpule indicates sterilizer failure. Biological Indicator StripsGeobacillus stearothermophilus and B. atrophaeus spores are stocked in dual species and single species formats. Custom population lots and B. pumilus spores for radiation process monitoring are also available. SPSmedical BI strips are manufactured with a two (2) year shelf-life under cool, dry storage. Each shipment includes a Certificate of Performance documenting spore population, spore resistance, D values and expiration date. Strip itself has lot number identification imprinted. Spore SuspensionFor use with process validation testing, Bacillus spore suspension in 10 ml vials are available in the following spore concentrations. Custom manufactured, allow 7-10 days for shipment. Steam Biological Test PackDesigned to routinely challenge the steam sterilization process in healthcare facilities, each pack contains a self-contained biological indicator and Load Record Card. When properly processed, the chemical indicator on the pack and Load Record Card will turn brown and the BI inside the pack will remain purple after full incubation. BI AccessoriesCulture Media, Transfer Rack, preset Dry Block Incubators and Record Notebooks are available as individual items. Incubators will accommodate all SPSmedical products and carry a lifetime warranty. SporView® PA Culture SetSporView PA Culture Set is the fastest biological monitoring system for the STERIS System 1 peracetic acid sterilization process. Product features include final readout in only 24 hours, room temperature storage, and fits existing incubators. Product is sold 25 tests per box and record notebook is available to store test results. Incubation time savings is significant when failures are detected and the sterilizer needs servicing.To obtain pricing and further information on the Namsa Range of Products please contact info@mactec.ie Chemical IndicatorsSPSmedical offers the industry's most complete line of color change chemical indicators designed to meet industry standards. Each CI product visually verifies that items have seen the sterilization process and should be used in conjunction with routine "spore testing" as part of an overall sterility assurance program. AirView Bowie Dick Test PackFor use daily to evaluate the efficacy of air removal and steam penetration in dynamic-air-removal steam sterilizers. The AirView Test Pack is single use, disposable and comes packaged 30 tests per case. Instructions for use are printed directly on each test pack to assist users and a proper test is shown when the indicator sheet turns uniform black after processing at the appropriate Bowie-Dick cycle parameters: 273ºF/132ºC for 3.5 - 4 mins. LANTOR CUBE® Reuseable Bowie Dick Test PackThis "new technology" product is the industry's first and only FDA approved reusable test pack. Certified to meet the AAMI standards for daily air removal check of Steam vacuum sterilizers, the Lantor Cube reduces waste, reduces inventory and saves money over single-use test packs. A Lab Report documenting performance and accuracy is available upon request. SteamPlus Sterilisation IntegratorPeace of mind is immediate with this "advanced technology" medical device. Scientifically engineered to integrate all 3 critical parameters of sterilization (time, temperature and saturated steam), the SPSmedical STEAMPlus Sterilization Integrator is certified to perform equal to a biological indicator plus an added safety factor. SteamPlus Tray Record CardPeace of mind is immediate with this "advance technology" medical device. Scientifically engineered to integrate all 3 critical parameters of sterilization (time, temperature, and saturated steam), the SPSmedical STEAMPlus Tray Record Card is certified to perform equal to a biological indicator plus an added safety factor. In the Tray Record Card format, you are provided legal documentation that sterilization has taken place. SteamPlus Steriliser Test PackDesigned to routinely challenge the steam sterilization process in healthcare facilities according to the AAMI guidelines. Each pack contains a Sterilization Integrator that provides an immediate read-out and is equivalent in performance to a Biological Indicator. When properly processed, the chemical indicator on the pack will turn brown and the dark bar on the Steam Sterilization Integrator inside the pack will enter the blue SAFE area. Special Note: An instructional CD-ROM is available upon request! Indicator LabelsPressure-sensitive, color change indicator labels are available for use with Steam, EO gas, Dry heat, Chemical vapor and Radiation sterilization processes. Indicator StripsFor use as an external or internal monitor, these color change chemical indicator strips can be written on and kept as a permanent record. Our proprietary DUAL Monitor Strip is certified for use with both Steam and EO gas to reduce inventory, cost and save money. Patient Record CardUtilized for tracking sterilized products directly to the patient they were used on. Tape to the outside of every package and apply a lot control sticker to the card. The OR then seperates it at the perforation and places it on the patient's chart. MiscellaneousThe steam indicator pen is a multiparameter, chemical indicator pen which allows users to identify and monitor items that are Steam processed. Indicator changes color from BLACK to RED when processed at 250ºF - 285ºF (121ºC - 138ºC). Unique, self-inking tip extends pen life. Works on nonporous surfaces only (i.e. metal, glass or plastic).The steam indicator tube is for use in monitoring liquid loads processed in Steam at 250ºF/121ºC. This unique product has a solid pellet that melts when proper conditions for sterilization have been met. To obtain pricing and further information on the Namsa Range of Products please contact info@mactec.ie Record Keeping ProductsCONTACT Label Applicator and LabelsSPS Medical "new technology" Contact Label Applicator is extremely easy to load, "jam-proof", lightweight and comes with a lifetime warranty against defects or breakage under normal use conditions. Dials up to 9 characters and prints a wide selection of labels manufactured with high tack adhesive, designed to stay secure to packs, before, during and after processing. Wavy Label Applicator and LabelsEconomically priced, SPS Medical offers a variety of products for use with Steam, EO gas and Gas plasma sterilization processes. Record Charts, Sheets and EnvelopesEconomically priced, SPS Medical offers a variety of products for use with Steam, EO gas and Gas plasma sterilization processes. Temperature and Humidity DevicesFor use in the daily recording of time, temperature and humidity per AAMI standards. Controlling temperature and humidity are important aspects of sterility assurance and employee comfort. The SPS Medical hygrometer clock offers a triple display with crisp readable dials for viewing time, temperature and humidity. Each clock includes a traceable calibration certificate which complies to ISO 17805.To obtain pricing and further information on the Namsa Range of Products please contact info@mactec.ie 3M
3M Load Control ProductsLoad control is the process by which a load is monitored and released for use based on the result of a biological or chemical indicator. 3M products are easy to use and can give results in as little as one hour. 3M™ Attest™ Biological Monitoring Indicators and Preset IncubatorsBiological indicators which are easy to use and give a colour change result within 24 to 48 hours of processing. 3M™ Attest™ Biological Monitoring Systems are true biological indicators, in self-contained indicator capsules. They enable checks on the biological reliability and performance of each sterilizer without laboratory facilities and laboratory trained personnel. 3M™ Attest™ Biological Monitoring Indicators
Product Benefits
3M™ Attest™ Dryblock Incubators
Product Benefits
To obtain pricing and further information on the 3M Biological Monitoring System Products please contact info@mactec.ie 3M™ Attest™ Rapid Readout Biological Monitoring SystemThe 3M™ Attest™ Rapid Readout Biological Monitoring System consists of true biological indicators, that provide clear, easy to interpret biological results in just 1-4 hours. These products may be purchased in single box quantities.
Product Benefits
To obtain pricing and further information on the 3M Rapid Readout Biological Monitoring Systems please contact info@mactec.ie 3M™ Comply™ Bowie-Dick Type Test SystemsBowie-Dick type test packs monitor sterilizer operation and air removal for vacuum-assisted steam sterilizers. Includes Comply™ Bowie-Dick Plus Test Pack with early warning test sheet, Comply™ Bowie-Dick Test Packs and test sheets. Bowie-Dick Test Packs are used for equipment control as a way to find out whether or not your sterilizer is doing its job properly. Bowie-Dick test packs should be used daily, after a sterilizer is installed, relocated, after sterilizer malfunction, after sterilization process failures, and after any major repairs of the sterilizer.The 3M™ Comply™ 00135 Bowie-Dick Plus Test Pack with Early Warning Test Sheet consists of chemical indicators on two test sheets positioned inside porous materials and sealed inside a CSR outer wrap. In addition to the regular Bowie-Dick test sheet, a sensitive early warning indicator sheet identifies problems sooner so the sterilizer may be repaired before it must be taken out of use. The 3M™ Comply™ 1233 Bowie-Dick Test Packs consist of a chemical indicator sheet positioned inside porous materials and sealed inside a CSR outer wrap. The 3M™ Comply™ Bowie-Dick Internal Steam Indicator Sheets are large-sized, test sheets used for health-care facility prepared, reusable towel Bowie-Dick test packs. All Bowie-Dick products have the same light-yellow chemical indicator that turns a uniform dark brown/black if the sterilizer is functioning. Any unexpected color change, such as the center of the test sheet being paler or a different color than the edges (i.e., there is a non-uniform color change) indicates that there was an air pocket present during the cycle due to sterilizer malfunction. Product Benefits
Please contact info@mactec.ie for further information on the following; 3M™ Comply™ Bowie-Dick Internal Steam Indicator
Sheets 00130 3M™ Attest™ Biological Indicator Incubators
Benefits
Suggested ApplicationsTo incubate Attest biological indicators. Please click for further product information 3M™ Attest™ Biological Indicators and Test Packs
BenefitsBiological indicator vials are easy to use and interpret with visual color readout in 48 hours.
Suggested Applications3M™ Attest™ 1262 Biological Indicators: To monitor 250°F(121°C) gravity and 270°F(132°C) vacuum-assisted steam sterilization processes.3M™ Attest™ 1276 Steam Packs and 3M™ Attest™ 441380 Steam-Plus Test packs: To monitor 250°F(121°C),>= 30 minute gravity steam processes, and 270°F (132°C), >= 4 minute vacuum-assisted steam processes. Make a Selection3M™ Attest™ Biological
Indicator Test Pack for 250°F/121°C Gravity and 270°F/132°C
Vacuum Assisted Steam Sterilizers 1262 3M™ Attest™ Biological
Indicator Test Pack for 250°F/121°C Gravity and 270°F/132°C
Vacuum Assisted Steam Sterilizers 1262P 3M™ Attest™ Biological
Indicator Test Pack for 250°F/121°C Gravity and 270°F/132°C
Vacuum Assisted Steam Sterilizers 1276 3M™ Comply™ Steam Indicator Tape 1222
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| Astech Ireland Ltd.,(Incorporating Mactec) Unit 8, Charvey Court, Rathnew, Co. Wicklow,
Ireland Tel: (+353) 0404 25070 Fax: (+353) 0404 25080 Email: info@astechireland.ie |
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