medical grade paper specification

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HealthCare™

Medical Grade Paper

Plastic based

The range of Amcor Healthcare Medical Grade Paper and Amcor Healthcare Medical Grade Pouches are made of a mix of paper and film printed with ETO, Formadehyde and steam indicator. It's available in flat or gusseted formats, meeting the requirements. The Medical Grade paper offers superior resistance, high barrier and ecological options for lightweight instruments and small trays

Applications

• In-Hospital

Customer benefits

• The high porosity, tough packaging material and process indicators, that comply with Medical and Hospital's requirements, ensures the sterility of the device inside.
• The indicators change color after sterilised to confirm the sterilization process.
• The laminated resistant film decreases the risk of tearing and puncturing when opening the pouch.
• The clean peel system ensure the no release of paper fibres increasing patient safety

End consumer benefits

• Easy to sterilize and store. Simple to keep and us
• Easier to handle sterilized devices

End consumer types

• Durable package
• Stand out print quality
• High quality indicators for the main sterilization process

Regions available

Latin America

Technical specification

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• Medical Grade Paper for Sterilization

Base paper for medical packaging that ensures safety and hygiene

Packaging material for medical devices needs to be safe and highly functional. Combining its paper making technologies and paper treating expertise, our medical grade paper possesses a high level of heat seal-ability and peel-ability, while maintaining a water repellent finish and superior bacteria barrier qualities.

Microbial Barrier Properties

Microbial Barrier Test The microbial barrier properties of KJ Specialty Paper's medical grade paper are demonstrated by MT Japan∗ method. ∗ Medical Technology Association of Japan

Pore Size KJ Specialty Paper's medical grade paper's pore size is controlled to provide the microbial barrier properties in accordance with EN 868 series.

Control of Foreign Matter and Inspection System

Control of Foreign Matter KJ Specialty Paper's medical grade paper is manufactured using the foreign matter detection systems.

Inspection System KJ Specialty Paper's medical grade paper is inspected at the dedicated facilities maintained at high level of cleanliness with air shower entry systems.

Biocompatibility and International Standards

Biocompatibility The biocompatibility of KJ Specialty Paper's medical grade paper is demonstrated based on ISO 11607-1(MEP-P series).

Quality Control based on International Standards KJ Specialty Paper's quality control for medical grade paper is performed based on the international standards such as ISO 11607-1 and EN 868 series(MEP-70EX1).

Well-balanced Sealing Strength and Peel Ability

Sterilization Compatibility

The sterilization compatibilities of KJ Specialty Paper's medical grade paper are as follows;

Both the uncoated and coated grades provide excellent permeability of steam and gases.

Product Dimension

Reel width and length of KJ Specialty Paper's medical grade paper are individually customized to meet the customers' specific requirements.

For inquiries about Medical Grade Paper for Sterilization, please call:

• Base Paper for Decorative Laminates
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Medical Grade Grid Lacquer Coated Paper

Polycoated-papers-7-s1.

polycoated-papers-8-s2

polycoated-papers-8-s3

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Safepack provides tailor-made solutions for packaging disposable single-use sterile medical devices/products which are being used in hospitals as well as polycoated OLB paper-based blister back material for tablet packaging in the pharma sector.

For the product “MediSafe”, base virgin Medical grade kraft/ OLB paper is coated with thin/thick layer of food-grade polyethylene polymer compound which makes the paper liquid tight, provides humidity protection as well as imparts excellent sealing properties. This polyethylene Barrier substance also provides effective protection against undesirable effects caused by light, humidity, grease, or heat.

Our Polycoated Medigrade Paper fulfills the industry’s requirement for high quality, hygiene and safety levels.

• Medigrade Kraft / PE
• Medical grade grid lacquer paper has high paper strength ensuring good wrapping quality.
• The special paper used has an excellent surface that gives superior printability.
• The polymer-coated paper offers good sealability.
• Excellent runnability on FFS machine.
• Environment friendliness & recyclability.

APPLICATIONS:

Packaging paper for

• Latex examination gloves
• Latex Surgical gloves
• Powder-free examination gloves
• Sterile surgical gloves
• Catheters & needles
• Medicine Tablets
• Multitude of Hygiene products……..

BRIEF SPECIFICATIONS:

• Grammage – 70 gsm / Custom
• Jumbo reel form 900 mm – 1850 mm
• Slitted coils – As per the requirement

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Sterilization Bag ProSys™ Steam 2 X 3-1/2 X 6 Inch White Open End Paper

Bag, autoclave (1000/cs).

• Made of 100% medical grade paper, which is porous to sterilant
• The moisture absorbent paper helps to dissipate condensate - helping to fight wet pack
• Validated for use inside of instrument trays and containers to hold separate items
• More …

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WARNING: This product can expose you to chemicals which are known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.p65Warnings.ca.gov .

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• The moisture absorbent paper helps to dissipate condensate - helping t …
• Validated for use inside of instrument trays and containers to hold se …

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• They are made of 100% medical grade paper, which is porous to sterilan …

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• To separate and protect small items
• Poly laminate is a barrier to sterilization; water repellent
• Made of 100% medical grade paper, which is porous to sterilant; moistu …

Sterilization Bag ProSys™ Steam 2 X 3-1/2 X 6 Inch Whit…

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Medical Grade Paper Bags

AAMI Standard ST79 makes clear, utilizing paper/poly pouches to separate small items in a wrapped or filtered instrument tray is forbidden. This is because the poly laminate is a barrier to sterilization and being water repellent may contribute to wet pack. These paper bags are the ideal and appropriate alternative.

Description

Comply with AAMI Guidelines by Using these 100% Medical Grade Paper Bags to Separate and Protect Small Items :

AAMI Standard ST79 makes clear, utilizing paper/poly pouches to separate small items in a wrapped or filtered instrument tray is forbidden. This is because the poly laminate is a barrier to sterilization and being water repellent may contribute to wet pack. These paper bags are the ideal and appropriate alternative. They are made of 100% medical grade paper, which is porous to sterilant. Further, the moisture absorbent paper helps to dissipate condensate – helping to fight wet pack.

Product Description

Comply with AAMI Guidelines by Using these 100% Medical Grade Paper Bags to Separate and Protect Small Items : AAMI Standard ST79 makes clear, utilizing paper/poly pouches to separate small items in a wrapped or filtered instrument tray is forbidden. This is because the poly laminate is a barrier to sterilization and being water repellent may contribute to wet pack. These paper bags are the ideal and appropriate alternative. They are made of 100% medical grade paper, which is porous to sterilant. Further, the moisture absorbent paper helps to dissipate condensate - helping to fight wet pack.

Specifications

Support documents.

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Tyvek® 2FS™

Recognized as a standard of excellence  for form-fill-seal and less demanding packaging applications, Tyvek ® 2FS ™ , a lighter form of medical and pharmaceutical packaging styles of Tyvek ® , offers outstanding resistance to microbial penetration , significantly reduced risk of package failure, compatibility with a broad range of sterilization methods , a low risk of device contamination , and the ability to withstand transportation challenges.

Outstanding Resistance to Microbial Penetration

Even under the most rigorous conditions in highly contaminated environments, Tyvek ® 2FS ™ is highly resistant to bacterial spores and other contaminating microorganisms. Microbial barrier test data consistently prove that all styles of Tyvek ® for sterile medical packaging—Tyvek ® 1073B, Tyvek ® 1059B and Tyvek ® 2FS ™ — hold out bacterial spores and test particles better than other commercially available porous medical packaging materials, including medical-grade papers. In addition, an accelerated aging study proved conclusively that Tyvek ®  2FS ™  shows no change in microbial barrier properties after withstanding extreme conditions.

Significantly Reduced Risk of Package Failure

The tough, continuous filaments of Tyvek ® 2FS ™ help protect package integrity from both product breakthrough inside and rough handling outside. Compared to medical-grade papers, Tyvek ® 2FS ™ has superior tear strength and puncture resistance.

Compatibility with a Broad Range of Sterilization Methods

Unlike medical-grade papers and films, Tyvek ® 2FS ™ is compatible with all of the most commonly used sterilization methods . These include:

• Ethylene Oxide (EO)
• Radiation (Gamma and electron beam)
• Steam (under controlled conditions)
• Low temperature oxidative

So no matter which process you use for your sterile medical packaging Tyvek ® 2FS ™ will retain its protective properties, color and flexibility.

Low Risk of Device Contamination

The unique structure of Tyvek ® 2FS ™ — tough, continuous filaments—creates a tortuous path that results in microbial barrier and strength properties superior to those of medical-grade papers. It also means that Tyvek ® 2FS ™ generates very few airborne particles when sterile form-fill-seal packaging is opened or handled. This clean peel minimizes the risk of introducing particulates into a clean environment.

Ability to Withstand Transportation Challenges

Another distinct advantage that Tyvek ® 2FS ™ has over medical-grade papers and films is its ability to withstand the significant temperature and pressure changes commonly encountered during shipping. Because it is breathable, Tyvek ® 2FS ™ minimizes the formation of condensation due to temperature extremes that can occur during transportation. This breathability also allows medical packages made with Tyvek ® 2FS ™ to equilibrate rapidly from the pressure changes that occur not only during shipping but also in storage environments.

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Sterilization Pouches

Steril Medipac’s sterilization pouches are made from certified medical grade paper with 60 - 70 gsm paper on the bottom web heat-sealed with PET/PP copolymer film on the top web. ISO 11607: 1 certified Medical Paper sourced from European paper Mills ensures clean peel (minimizing airborne lint particles emanating) during the opening of the paper sterilization pouches. Process indicators for steam and ethylene oxide sterilization can be applied on the paper surface and help to differentiate between sterilized and unsterilized packages. Stringent Quality checks such as checking for uniform seal width, peel strength, external and internal pouch dimensions, accuracy of thumb notch positioning are carried out on all Pouches to ensure Sterilization performance and safety of packaged medical packaging devices.

Significant Features of Sterilization Pouches:

Available in Transparent, Tinted Blue or Tinted Green Top web.

Medical Paper pouches can be made with a thumb notch for ease of opening the pouch.

Sterilization Pouches and rolls have imprinted Sterilization Indicators positioned outside the actual packing area to prevent ink imprints from seeping into the paper and contaminating the packaged product.

Conform with international norms EN868.

Easy to seal with all types of sealing machines.

Frequently Asked Questions:

Ans: Medical grade paper is made out of strong long fibre virgin wood pulp. Special additives are mixed in paper pulp for preparing the surface of paper so that paper fibre doesn’t give away while the pouch is peeled open.

Ans: Medical grade paper is normally available in 60 and 70gsm grammages.

Ans: Medical sterilization pouches are not considered suitable for gamma sterilization. Aluminium foil pouches or Tyvek ® pouches are the preferred choice for gamma sterilization.

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