Instructions on Bromohalobutyl Rubber Stoppers Ready-for-sterilization (RFS)
[Product Name]
Full name: Bromohalobutyl Rubber Stoppers Ready for Sterilization (RFS);
Abbreviation: RFS® rubber Stoppers.

[Prescription Composition]
Brominated Halobutyl rubber, calcined Kaolin, curing agent, accelerator, plasticizer, pigment.

[Production Process]
[Rubber Stoppers Characteristics]
1. Our Bromohalobutyl Rubber Stoppers are cleaned by purified water, which conforms to the requirement of “Pharmacopoeia of the People's Republic of China".
2. Packaged by RFS® packaging bags which have sterilization function.
As a result, during the cleaning and packaging process, we have succeeded in eliminating endotoxin, microorganism forming system and visible & invisible particles on rubber bottle closures. And there is no need of siliconizing and cleaning etc. before our Stoppers are used in pharmaceutical packaging (Sterilization is necessary).

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[Usage and Preservation]
(1) Preservation for RFS® Bromohalobutyl Rubber Stoppers:
Dry, ventilating and no chemical pollutants places;
Avoid direct light;
Temperature: < 30℃;
Carton piling: < 5;
(2) Sampling: A carton of rubber Stoppers is prepared for convenient sampling.
(3) Package open: the outer packaging (carton box) should be open carefully, for example, the packing belt should be cut off and the carton sealing tape should be ripped off by sharp tools.
(4) Usage:
Firstly, filtered gas should be adopted to blow away the foreign substances on the outer PE packaging bags for Stoppers;
secondly, transmitting the cleaned packaging to class 30 cleanroom and blowing away foreign substances once again by filtered air;
thirdly, transmitting the PE packaging to class 100,000 cleanroom and taking off the first layer of outer packaging;
fourthly, transmitting them to class 10,000 cleanroom, and blowing away foreign substances on the inner PE packaging bags by filtered air or cleaning the bags by spraying ultra-clean ionic water on it;
fifthly, to cut off the second layer PE packaging bag carefully; and then take out the RFS® packaging bags and put them in autoclave sterilizers
(note: 1. milky TYVEK side should be face up evenly; 2. sterilizing temperature: 121±2℃; 3. sterilizing time: 30 min; 4. the sterilizing cannot finish until the sterilizing indicator turn to brown)
sixthly, aseptic drying in cleanroom and then cooling to ambient temperature;
finally, the Bromohalobutyl Rubber Stoppers can be used for pharmaceutical packaging.
NOTE:
1. All packaging (carton or PE packaging bags etc.) should be open carefully and in specified area.
2. RFS® packaging bags should be checked carefully and guarantee that there is no any breakage before sterilizing.
3. RFS® packaging bags is only suitable for steam sterilizing.
4. The highest sterilizing temperature should be under 125℃.

[Introduction of RFS® Packaging Bags]
1. Product standard:
(1) Full name: Ultraclean Cleansteam® Bags;
(2) Material: milky side: TYVEK1073B of DU Pont; transparent side: multilayer HDPE;
(3) Material characteristics:
TYVEK1073B of DU Pont: no coating and no anti-static processing; no corona-crepe corona treatment;
HDPE: good mechanical characteristics and high temperature stability;
Both kinds of material are good aseptic packaging material.
(4) Cleanliness: MIL-STD-1246C Level 200;
(5) Seal strength: average strength: 30N/15mm; min. strength: 20N/15mm;
2. Protective packing:
Our aseptic packaging is ISO9002 certificated;
(1) DUPONTTYVEK (raw material of our packaging bags) is a kind of laminated structure material and is composed of spunbond olefin fibers; and the interlocking fibers are bonded together by heat and pressure; as a result, our packaging bags generate no or little fibre flocks for friction and generate no particles at any time. And pollution to wrapped products can also be avoided for the high density, high strength and wear resistance of TYVEK.
(2) HDPE is a kind of hygienic packaging sealing material which can provide excellent barrier against microorganisms. It is suitable for packing injections and related products. Generally speaking, it can keep the TYVEK products under aseptic state for 5 years.
(3) TYVEK allows water vapor passing through, but not liquid water. The packaging size can keep stable even under a high temperature of 125℃ while sterilizing.
(4) A 25,000 sq.ft cleanroom (class 100 cleanliness) guaranteed an aseptic production process; (conforming to FED-STD-209 standard)
(5) Thoroughly sterilizing: sterilizing level can be displayed through sterilizing indicator.
[Packaging for Rubber Stoppers]
1. Outer packaging: corrugated carton box (tape sealed and protected by two lines of packing belts) printed with words “Rubber Stoppers Ready for Sterilization"
2. Three layer of inner packaging: the outer two are aseptic PE bags and the innermost packing bag is RFS® bag.

[Manufacture Date]
Printed on the carton surface.

[Manufacturer]
Aoxiang Pharmaceutical Packing Co. Ltd, Zhengzhou
Add: High & New Technology Industrial Area, Sanlizhuang, Dengfeng City, Henan Province, P. R. China
Zip code: 452483
Tel: +86-371-2768370
Fax: +86-371-2768351