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Sterilization Packaging Solutions
Capabilities and Quality	World class medical grade laminates and medical grade paper for production & ensure adherence strict quality control.
	OEM capabilities We work with and offer India's leading healthcare and pharmaceutical companies custom OEM packaging solutions.
Steam / EO Sterilization Rolls (Heat Seal) Steam / EO Sterilization Rolls General Information : Mechanix flat and gusseted reels & pouches are manufactured according to EN 868 and ISO 11607-1 standards. These are manufactured using high quality medical grade papers and medical grade poly laminate. The sterilisation indicators printed on the paper is classified under EN ISO 11140 Class 1 process indicator.Our product meets the required international norms of 93/42/EEC of Medical Device Directive Regulations. Intended Use : Sterilisation Medical Packaging plays a vital role in assuring the sterility of medical devices and instruments from manufacture to point of use. Applying effective heat seals and using quality medical grade paper to the package of terminally sterilised medical devices are arguably the most critical steps to ensure the aseptic presentation of a product when it comes into contact with an end user or patient. The package must remain sterile till the time of end use.Mechanix provides you a complete solution for packing your medical devices.Our products are meeting all the stringent requirements to manufacture these kind of products.The medical devices packed in our products remain sterile till the time of intended use and are storable upto 5 years in clean room conditions.We are associated with the leading hospitals and medical device manufacturers having different grades of medical grade papers for your requirements of different sterilisation methods.	Sterilization technique	Initial Colour		Processed Colour
	Steam		Pink to Cocoa / Black
	ETO		Blue to Yellow / golden Brown
	Sizes		50 mm * 200 meters	75 mm * 200 Meters
			100 mm * 200 Meters	125 mm * 200 Meters
			150 mm * 200 meters	200 mm * 200 meters
			250 mm * 200 meters	300 mm * 200 meters
			350 mm * 200 meters	400 mm * 200 meters
			450 mm * 200 meters	500 mm * 200 meters
Steam / EO Sterilization Flat pouches (Heat Seal , Self Seal) Steam / EO Sterilization Flat pouches (Heat Seal , Self Seal)	Sizes		125 mm * 145 mm	250 mm * 350 mm
			145 mm * 180 mm	250 mm * 300 mm
			450 mm * 500 mm	200 mm * 320 mm
	Upto 4 Colour customised printing
	Customised pouch sizes as per customer need
Sterilization Indicators and Integrators
Steam	Steam Integrator Type 5 Steam Integrator Type 5 Type 5 Integrating indicator indicator provides a reliable indication of the quality of the sterilization process, but only where it was placed After opening a sterile package and checking the correct colour change the self-adhesive indicator is removed from the package and glued into the OR protocol.
	Bowie dick simulation test strips Bowie dick simulation test strips Bowie-Dick-Simulation (BDS) Test is daily used after start up as a func-tionality check (type test, no sterility test) for steam sterilizers. It has to be carried out in an empty sterilizer chamber. The BDS test is no substitution for routine monitoring. For rou-tine monitoring batch/process monitoring sys-tems or type 5 or 6 indicators in each package should be used. Table top sterilizers according to EN 13060 type B do not require a Bowie-Dick Test but a hollow load type test according to EN ISO 11140-6. However, some sterilizer man-ufacturers demand the daily use of a BDS-test during start-up. BD indicator strip has to be placed into the PCD device and the cap has to be tightened. The test device should be placed close to the bottom and near the door of the chamber on a stainless steel tray into an empty sterilizer chamber. This test can be used in Bowie-Dick-Test programs at 132-137°C (270-279°F); 1-3.5 min or 121°C (250°F); 15-30 min. If this BD-cycle is not availa-ble, a normal cycle of 132-137°C for up to 9 min may be used without losing sensitivity. If all six bars of the chemical indicator turn from Magenta to black it is an indication of suffi-cient steam penetration inside the PCD. A posi-tive result ensures that the sterilizer works ac-cording to the sterilizer specifications.
	Bowie dick simulation test pack Bowie dick simulation test pack
	Bowie dick simulation test A4 Sheet Bowie dick simulation test A4 Sheet
	Batch Monitoring System PCD Batch Monitoring System PCD Batch Monitoring Systems (BMS) are used for routine monitoring in steam sterilization processes in each cycle to detect insufficient air removal, leaks and/or non condensable gases (NCG) in steam. Monitoring temperature and pressure alone does not provide sufficient information to ensure steam penetration. The gke BMS is a Type 2 indicator according to EN ISO 11140-1, consisting of a ,,specific test load" (Process Challenge Device = PCD) and "indicator system" (indicator strip). The BMS is a hollow load test according to EN 867-5 BMS Test strips for use in PCD System. Load release. Self-adhesive strips printed with indicator ink , for Steam sterilization processes. Metals free 7 min. 134° C. Turns from Yellow to Black. ISO 11140-1 Type 2c If the 4 bars reach the final color, the result can be considered successful, which means the sterilizer is working correctly. If one bar doesn€™t reach the final color, it means that residual air is present in the sterilizer, therefore a malfunction of the equipment The reasons for the failure can be insufficient air removal, leakages and noncondensable gases in steam. We suggest to perform the test once again, before sending the equipment to technical service
ETO	Type 4 Package monitoring indicator Type 4 Package monitoring indicator Package indicator Type - 4 self-adhesive indicators according to DIN EN ISO 11140-1 type 4 used in packages and containers For monitoring ethylene oxide sterilization parameters and for patient documtation
	Type 5 Integrating indicator Type 5 Integrating indicator Type 5 Integrating indicator indicator provides a reliable indication of the quality of the sterilization process, but only where it was placed. After opening a sterile package and checking the correct colour change the self-adhesive indicator is removed from the package and glued into the OR protocol

Hospital linens	Big hole sheet 70” * 55”
	Big plain sheet 70” * 55”
	Big Single hole sheet 70” * 55”
	Wrapper Single Layer 40” * 40”
	Wrapper Double Layer 40” * 40”
	Small Hole sheet 27” * 27”
	Surgeon Gown
Dressing material
Dressing Material		Gauze Swabs Gauze Swabs	7.5 cm * 7.5 cm	Ready to Strile Pack with Indicator
			10 cm * 10 cm With X-Ray Thread
		Mop Sponge Mop Sponge	30 cm * 30 cm * 12 pli With X-Ray Thread
		Gamjee Rolls Gamjee Rolls	10 cm * 2.5 meters	Ready to Strile Pack with Indicator
			15 cm * 2.5 meters

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