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Sterilization Packaging Q&A 

Sterilization Packaging Q&A

1.What is the sterilization packing for medical instrument?
Defined as EN-868 & ISO-11607, it is the primary packaging for medical instruments with microorganism Barrier, Sterilizable, and sustained and Shelf-life performances


2. How to design for sterilization packing of disposable medical instruments?
When choosing sterilization packing for medical instruments, you should consider factors as following:
a. methods of sterilization
b. volume and weight of the loading instrument
c. Validated date
d. convenience of use


3.may medical sterilization paper to film pouches be printed in multicolor or complex contents? And what contents have to be printed on the pouches?
a. As EN-868-5,printing can not be more than 50% of pouch in area, and the ink must not reach the instruments inside. So medical packing is not fit to printed complex contents but the simple is better.
b. As “The Standard Medical instruments marks and management” published by FDA in USA, general requirements suitable for all the medical instruments include company name and address (marks of the medical instruments should contain manufacturer of the instruments, company of packing and dealers’ name and detailed address with street, city, state and zip code); sufficient instructions (instructions should be able to guarantee ordinary users can use equipment safely, and the device can achieve the intended use. That is, all the intended use and the applied scope, all intened use and all intened quantities of patients with different ages and physical conditions, frequency of use, duration of use, maintenance cycles of instruments and other factors should be considered, or applied ways or methods, the necessary preparations before use)


4. Why the printing of the medical sterilization packing with paper and film can not be printed so exquisite as that of CCL printing (for example color booklet) ?
Stated clearly in EN-868-1, all to be used for materials of sterilization packing should be sterile. All packaging materials required as a non-toxic disinfectant.  At present, the usual printing methods, such as intaglio, lithography, copperplate and so on, all of them use oily ink. There are risks their volatile content will pollute apparatus. It is better to  use non-toxic water-based ink whose solution is water-based solution. But water-based ink should be printed on flexographic printers, there are some technical restrictions of flexographic printing in certain conditions, such as network points, shadow, color, tiny printing and so on, it  can not be so simple as other printing methods. But packaging medical sterilization is only the rough packaging, so it only need to print the essential illustration on it but the multi-color printing or tiny printing is unnecessary.


5. All films packing can use ETO sterilization?
a. Even if the plastic film have apertures can let the gas through, its porosity is not so good as that of the Medical Grade Paper, so it will have some problems on gas input or output. So there will be inadequate sterilization or gas left in the pouch when all plastic pouch loading the instruments are used in ETO sterilization.
b. At present, Standardization Administration of P.R.C have stated in douments instruments for only one use must use the breathable(can be sterilized) packing. For examples in GB 8368-2005 “Infusion sets for single use,gravity feed”, it stipulate materials for packing must use the breathable materials conforming to GB/T 19633-2005 “Packaging for terminally sterilized medical devices”


6. What are the differences between Breath Papers from foreign and Breath Papers form China?
At present, it is very indistinct that the says “Breath Papers from foreign” and “Breath Papers form China” in medical packing market. In fact, they should be distinct in “medical grade paper” and ” food grade paper”. Medical grade paper should conform to international standard of  EN868 or ISO11607, and can be used for raw paper for medical packing. But “Breath Papers form China” called now can not be offered valid test report what can prove it conform to medical packing materials norms. We, Suzhou Sigma Medical Supply Co., Ltd usually use medical grade paper supplied by ARJO WIGGINS in France, and we are the Exclusive agent in China of ARJO WIGGINS


7. Can the medical pouches suit for all kinds of sterilization conditions?
In general, different materials suits different sterilization methods. You’d better choode best sterilization method base on our advices


8. What is the best condition of the sterilization pouches? How long the stored time should be?
(1) Our recommended stored condition: Temperature: 25°C ± 2°C, keep dry and away from the strong light
(2) ordinary advised stored date: 3 years


9. Have medical pouches to change packing after resterilizing? And after resterilizing, does it have validity date of 6 months?
No. Because medical pouches are assumed for only one use. So resterilized, its mateial will be impacted. Relatively, it can not offer the guarantee to the stored validation date of the contents. In a word, to assure the sterilization quality, please change the packing and resterilize and do not resterilize medical pouches only one use after the validation date of 6 months.


10. What condition the sterilization pouches are manufacted in?
In accordance with sterile medical equipment production standards Appendix B-B.5 in pharmaceutical industry standards of PRC. And the 6.1.1 of “production Implementation Rules of single-use sterile medical devices” issued by the SDA(State Drug Administration), there are stipulations packaging pouches should be produced in the 300,000 level of aseptic workshop. Our producing plant pass the test to be the workshop of 100,000 level, so our production conditions can absolutely be relied.


11.Do medical pouches, sterilization indicator tapes, medical sealer and so on need products deposit of the medical struments?
a. Medical pouch:
 As SFDA Certified No.84 (2004)(iinformation) on March 23rd,2004 of SFDA, in its 30th item, it is stated as: sterilization packing paper: Sterilization packing for operation instruments is not be administed as medical inatruments
b. sterilization indicator tapes: As SFDA Certified No.53 (2004)(iinformation) on March 23rd,2004 of SFDA, in its 30th item, it is stated as: Sterilization indicator tape(card or pouch): It is used for indicating the sterilization results and have no sterilization functions in itself, so it is not be administed as medical inatruments
c. medical sealer: As SFDA Certified No.154 (2005)(iinformation) on April 15th,2005 of SFDA, in its 28th item, it is stated as: medical sealer for sterilization pouches: it is used to seal the sterilization pouches, so it is not be administed as medical inatruments


12. How to identify the indicators on the medical pouches?
EO&STEAM in arrow printed on the medical pouches, are to tell user whether the products are sterilized program. The color changing as following: EO: Pink->Yellow; Autoclave: Light Blue->Light Coffee


13. Can the sterilized date be printed on the medical pouches?
In general, sterilized date should be printed by hospital. Besides the traditional seal, most hospitals use the sealer machine with functions printing the date or barcode (for example, HAWO hm850DC)


14. How to set the sealing temperature for the medical pouches?
In general, it will be based on the sterilization methods and the types of the pouches
a) Paper w/ CPP/PET: 180 – 200 °C
b) Tyvek w/ PE/PET: 110 – 130 °C


15. Are there any limits on the sizes of the medical pouches?
Generally, we do not have the strict restrictions on the sizes of the rolls and we make the customers’ requirements as our direction. So we will meet your requirements only if you can offer your requirments clearly and your quantities are more than our Min quantities.


16. Are there clear instructions on the loading weight about the sterilization pouches?
In general, both of sterilization contents’ weitht or volume and the size of the sterilization Rolls used will impact the loading weight of the Rolling. So it is impossible to offer exact figures or standards


17. Can anything be packed in the medical pouches then be sterilized?
In general, it will need to consider the materials and the identity of the items to be sterilized. For example the sponge or other diagnosing equipment need to be considered what sterilization method suits forits material 

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33 Mulin Rd., Yuexi, Suzhou, China 215104

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