跳至主要内容

sterile pouch

Material
  Paper+Film●In the 121 ℃ discharge pressure steam sterilizer for 20 minutes, or in 132 ℃ ~ 134 ℃ in the vacuum pressure steam sterilizer 4 ~ 6 minutes.Observe the instructions of sterilization and discoloration on the paper to indicate that the sterilization process is completed.
 ●Or placed in ethylene oxide sterilization chamber,After epoxy ethane concentration to 600 + 50 ml/l, temperature 50 ℃, humidity 65% ~ 80%, 3 hours sterilization.Observe the instructions of sterilization and discoloration on the paper to indicate that the sterilization process is completed.
  Application: hospital supply room is used for sterilization package of medical instruments.
Quality Technical Requirements
1.    Including materials must be effective against microorganisms/bacteria  ASTM F-1608
2.    Must adapt to promised sterilization methods ISO11134\ISO11135\ISO11137
3.   Maintain products sterility.Packaging should not have the opportunity to be contaminated by air, fiber breakage, dust and other foreign matter, microbial invasion（ASTM D- 2019）.Therefore, packaging needs to be ensured:
  --Including material without damage.
--Sealing integrity, suitable peeling strength（ASTM F88）, no penetration（ASTM
F1929:1998）, no blasting(ASTM F-1150 / ASTM F-2054), stripping clean（EN868-5）
4.   Including materials or packaging shall be suitable for subsequent processing;
When making materials, the loss of particles must be minimized.For example,fiber, sheet, ink off, dust（ASTM D-2019）.
5.   When the package is opened, there should be a clear indication that it has been opened;
 After opening the package, there should be no arbitrary resealing.(Prevent packaging from opening and closing after being contaminated)
6.   Open position and direction should be identified;
  It should be easy to open and the position should be convenient for the user to open
7.      It have to be able to identify the product(The printed marks shall conform to the laws and regulations of medical devices.Includes materials that have a transparent side and can see the products inside.)
 Put the instrument which will be in final sterilization into the packaging bag.  After being sealed, the microorganism on the instrument inside the bag can be killed by physical or chemical method, and the device inside the bag can be kept in a sterile state within the specified period of validity.Include the following functions:
  --Suitable for the corresponding sterilization process
  --Protect the device and keep it in an acceptable condition
  --It has bacteria resistance and can keep the sterility and integrity of the instrument before use
  --It can be opened aseptically to use the instrument
  -- Identify and use the product correctly

评论

发表评论

此博客中的热门博文

Reference Standard For Seal Verification of Sterilization Pouches For Medical Devices

With the increasing demand for  sterilization pouches  of medical devices, quality and safety inspection have become more and more stringent. sterilization pouches of medical devices (blister box +  tyvek roll  material,  sterilization paper bag , etc.) as a form of packaging directly in contact with the device and used to block microorganisms. No matter what form of packaging, it has two characteristics, which can meet the sterilization operation and remain sterile until the transportation conditions are used. Therefore, relevant departments began to focus on the review requirements of sterile packaging and make specific requirements for its performance and quality.   As we all know, GB/ t19633-2005 "packaging of ultimately sterilized medical devices" is one of the authoritative standards in the current sterile packaging standards. It is equivalent to iso11607-2003 "packaging of ultimately sterilized medical devices". Clarify the basic performance req...
10 条评论
阅读全文

What is Self Seal Sterilization Pouches

  self seal sterilization pouches  is carried out in hospitals and medical or surgical sterilization manufacturing plants. Most packaging must be sterile when delivered to the end user. Medical self seal sterilization pouches provides protective envelopes for sterilization to protect against sterilization during disinfection, transportation, storage and delivery to the final home. Medical self seal sterilization pouches can assemble and secure several sterilization items required for a given surgical procedure and be ready for operation.   The term "sterilization" covers a wide range of products. A cotton ball, a cotton swab, and a tongue spatula are examples of "treatable products." Use them once and throw them away." Use once is not a synonym for cheap. Some very expensive sterilizations, such as dialysis filters, are themselves too fragile to be cleaned and reused after sterilization. To save costs, reuse is desirable. Most medical sterilization, such as sci...
2 条评论
阅读全文

Medical Non-Woven Fabrics And Biocompatibility Testing

  一、General situation of medical non-woven fabric industry Since the 21st century, especially after SARS in 2003, nonwovens technology has made great progress.With the continuous growth of consumer demand, a complete supply chain system has been formed for the processing of non-woven products, raw material production and equipment manufacturing, especially for the production and application of  medical non-woven fabrics . With the improvement of people's living standard, as well as the improvement of medical and health services, medical non-woven fabric market penetration and consumption gradually increase, while the progress of technology make medical non-woven fabric on technical level, protective function has greatly promoted, the export enterprise production of high-performance, high-quality medical non-woven popular in the United States, Japan, Europe, Oceania and other places, has five medical non-woven most developed markets, in order: the United States, Europe (mainly ...
发表评论
阅读全文