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Sterilization Pouch


Medical grade disinfecting paper (60g/m2 or 70g/m2) Transparent film (white/blue/green) Use non-polluting ink Using steam, EO chemical indicator Suitable for use in hospitals, laboratories and dental clinics Beauty supplies, tattoo or piercing supplies Size: 50x200mm,55x200mm,75x200mm,lOOx200m,150x200mm,200x200mm 250x200mm

Regulatory CE MDR 2017/745 Standard
Quality ISO 13485 Certified System
Compliance FDA 510(k) US Market Cleared
Facility GMP Audit Production Safety
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Sterile Supply · CSSD · Instrument Reprocessing
Self-Seal Sterilization Pouch
Medical-grade paper/plastic film sterile barrier system for instrument reprocessing. ISO 11607-1:2019 and ISO 11607-2:2019 compliant. EN 868-5 tested — seal strength ≥1.5 N/15mm (steam). Pre-applied adhesive self-seal closure. Type 1 external chemical indicator included. Compatible with steam (autoclave) and EO sterilization.
ISO 13485 CE MDR 2017/745 ISO 11607-1 & -2 EN 868-5
≥1.5 NSeal strength / 15mm (steam)
15–25°CStorage temperature (40–60% RH)
5 yrsUnsterilized shelf life (correct storage)
Product Features
Why Kingphar Sterilization Pouches
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Self-Seal — No Equipment Required
Pre-applied adhesive strip on open end. Remove protective liner, fill instrument, press flap to close. No heat sealer required — ideal for dental practices, clinics, and low-volume reprocessing settings. Three factory-sealed sides; one adhesive-sealed side.
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Medical-Grade Paper Porous Layer
EN 868-3 compliant medical paper — allows steam and EO sterilant to penetrate, and air to evacuate during sterilization cycle. Transparent PET/PP film on the opposite face for instrument visibility without opening the pouch.
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Type 1 Chemical Indicator
ISO 11140-1 Type 1 external process indicator printed on paper face — changes colour when exposed to sterilization process, distinguishing processed from unprocessed pouches. Minimum required indicator level for all sterilization pouches.
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EN 868-5 Seal Strength ≥1.5 N/15mm
Seal strength tested per EN 868-5 / ASTM F88 at 200 ±10 mm/min. Meets the minimum ≥1.5 N/15mm for steam sterilization processes and ≥1.2 N/15mm for other processes. Peel-open is continuous and homogeneous — no film delamination on opening.
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Transparent Film Side
Transparent polyester/polypropylene film allows visual inspection of instrument contents, folding, and any contamination without opening the sterile barrier. Instrument identity and condition visible at point of use.
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ISO 11607 Declaration of Conformity
Full Declaration of Conformity to ISO 11607-1:2019 and ISO 11607-2:2019 (both confirmed current in 2024) provided with orders. EN 868-5 test reports with numeric seal strength values available on request.
Chemical Indicator Types — ISO 11140-1
Understanding Indicator Levels
T1
Process Indicator
Confirms exposure to sterilization process. Does NOT confirm all parameters were achieved. Minimum requirement. Present on all Kingphar pouches.
T4
Multi-Variable
Reacts to two or more critical process variables (e.g., temperature + steam). Higher assurance than T1. Available as internal indicator upgrade.
T5
Integrating
Reacts to all critical sterilization variables. Performance equivalent to biological indicators. Highest chemical indicator level. Available on request.
T6
Emulating
Cycle-specific — validated for named cycle parameters only. Highest specificity. Available for specific cycle configurations.
For critical instrument reprocessing — specify internal Type 4 or Type 5 indicator
Type 1 external indicators confirm the pouch passed through the sterilizer — they do not confirm that all three sterilization parameters (time, temperature, steam) were achieved at the instrument level inside the sealed pouch. For surgical instrument reprocessing, specify pouches with both external Type 1 and internal Type 4 or Type 5 indicators. Contact Kingphar to discuss indicator upgrade options.
Sterilization Compatibility
Critical: Paper/Film Pouches Are Not Universal
Paper/film pouches are NOT compatible with hydrogen peroxide plasma sterilization
Paper absorbs hydrogen peroxide and interferes with the plasma sterilization process — leading to sterilization failure even if the cycle completes. For plasma sterilization (STERRAD and equivalent systems), only Tyvek/film pouches are appropriate. Kingphar paper/film pouches are compatible with steam (autoclave) and ethylene oxide (EO) sterilization only. Do not use for plasma sterilization.
Sterilization methodKingphar paper/film pouch compatible?Alternative if not compatible
Steam autoclave✓ Compatible — primary intended use—
Ethylene oxide (EO)✓ Compatible—
Formaldehyde✓ Compatible—
Hydrogen peroxide plasma✗ Not compatibleTyvek/film pouch required — contact for Tyvek options
Technical Specifications
Product Specification Reference
ParameterSpecificationSource / Notes
Porous layerMedical-grade paper — EN 868-3 compliantAllows sterilant penetration and air evacuation
Film layerTransparent polyester/polypropylene (PET/PP) filmInstrument visible without opening
Sealing methodSelf-seal — pre-applied adhesive strip, protective liner removed before useNo heat sealer required
Seal strength (steam)≥1.5 N per 15 mm widthEN 868-5 / ASTM F88 — actual test report available
Seal strength (other methods)≥1.2 N per 15 mm widthEN 868-5
Peel-open characteristicsContinuous and homogeneous — no film delaminationISO 11607-1 requirement for aseptic presentation
Chemical indicatorType 1 (ISO 11140-1) external process indicator — standard. Internal T4/T5 available on requestType 1 minimum on all pouches
Storage — unsterilized15–25°C · 40–60% RH · away from UV/fluorescent lightCardinal Health IFU reference
Shelf life — unsterilizedUp to 5 years from manufacture when stored correctlyConfirm with actual batch date
Fill volumeMaximum ¾ of pouch volumeAllows air evacuation and sterilant penetration
Standards complianceISO 11607-1:2019 · ISO 11607-2:2019 · EN 868-5Both ISO 11607 parts confirmed current 2024 — Declaration of Conformity provided
RegulatoryCE (EU MDR 2017/745) · ISO 13485 · FDA registeredSFDA registration support for GCC supply
Applications
Suitable Reprocessing Settings
Dental practice instrument reprocessing GP / clinic minor surgery Outpatient procedure rooms Veterinary instrument sterilization Podiatry and chiropody Hospital CSSD (heat-seal available) Tattoo and piercing studios Laboratory instrument packaging
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EN 868-5 test reports · Custom sizes · Arabic labeling for GCC
Numeric seal strength test reports provided. SFDA registration support. Tyvek/film variants for plasma sterilization available on request.
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ISO 13485 · CE MDR 2017/745 · ISO 11607-1 & -2 · EN 868-5 tested · SFDA support

Frequently Asked Questions

Quick solution center of gravity

Pre-Purchase

  • We contronl everthing from the raw material to the finished product.Not only can reduce cost but also can grasp the quality
  • Aprofessional manufacturer of gauze, non-woven, cotton and mask  related products with more than 30 years experiences.
  • Customized production can be made according to customer requirements
  • Our certificate,product related all kinds of documents are complete,and do certification experience
  • We export over 100 countries like USA, GERMANY,POLAND,can gibe the xustomer certain reference opinion.
  • Our annual export can be up to CHINA TOP 10
  • Commerce department double white list
  • Professional OEM manufacturer for 30 years First 500 China National Business Credit Enterprises Market covers over 60 countries and regions Service available 24*7,solve your problem at any time

We can provide OEM/ODM services. We have a professional design and production team, that can
produce according to your requirements.

Please contact our custom service to advise your detail request,we will offer some sample for free,
you only need to pay the postage charge. If you already play orders,we will send free samples by our account

Always a pre-production sample before mass production;
Always final Inspection before shipment;

Post-Purchase

We accept FOB, CIF, etc. You can choose the one which is the most convenient or cost effective for you.

Normally 5 day after receiving your payment, but it can be negotiated based on order quantity.

We work with TNT, FedEX, UPS, EMS, DHL to supply you with the best, fastest and safest courier services. It will take about
3-10 days.

Step 1: Confirm the order details (design/art-work, material, quantity, size etc)
Step 2: Pay the deposit
Step 3: Start production
Step 4: Finish production and quality checking
Step 5: Arrange the balance
Step 6:Ship out goods and provide tracking number
Step 7: Receive the goods
Step 8: Give feedback (in order to improve our production and service)

We ensure the quality of the products, and in case of misfortune, we will replace the defective products free of charge according to the quantity of the order

Size

50x200mm, 55x200mm, 75x200mm, 100x200m, 150x200mm, 200x200mm, 250x200mm, 300x200mm,, 350x200mm, 400x200mm

Transparent film

white, blue, green