跳至主要内容

The introduction of sterilization packaging

In the medical and health field, sterilization packaging mainly has the following four requirements:
1. The packaging materials must allow the sterilant to penetrate effectively and match the sterilization method.
2. The packaging material must ensure the sterility of the contents until the package is opened.
3. The packaging material should facilitate the aseptic operation when the user opens the sterile bag, and should not pollute the articles.
4. The contents in the sterile bag should Sterile when used.
The FDA lists aseptic packaging materials as Class II (potentially risky) medical devices. The use of contaminated instruments during surgery can be fatal. Therefore, the personnel of the disinfection supply center should select suitable packaging materials. Anqing Kangminna Packaging Co., Ltd. obtained US FDA certification in 2017 and provided the high-quality medical sterilization packaging products including self-seal sterilization pouches、heat-sealing sterilization pouches、Wrapping material crepe paper、non-woven fabrics etc.
http://www.kmnbz.com/Article/theintrodu.html

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

Medical Sealing Machine Operation & Maintenance Manual（I）

  I. About Thank you for choosing  KM100 series of sealing machine . To maximize its performance,please carefully read this manual and install and operate it by strictly following this manual to ensure its safety and reliability in use. We recommend placing the manual in an accessible place for better reference during the operation. II. Applied Area Automatic  medical sealing machine , 100-L series, is capable of continuous paper-plastic bag, 3D paper-plastic bag and paper-paper bag sealing. The sealing process satisfies the requirements of high-temperature steam sterilization, low-temperature ethylene oxide sterilization, hydrogen peroxide plasma sterilization and radiation sterilization. Seal quality meets corresponding international standards and GMP recognition. Sealable materials: Compliance with EN868-5 and YY/T 0698-5 bags and volumes; Compliance with EN868-4 and YY/T0698-4 paper bags; High density polyethylene materials (such as Tyvek); Aluminum foiled materials. ...
发表评论
阅读全文

Definition And Use Of Sterilization Or Chemical Indicator

  Sterilization indicator  tape and label   Definition: Wrinkle paper or label paper as the base material, coated with color-changing ink as sterilization indicator, back coated with pressure sensitive adhesive.  The indicating tape used for chemical monitoring outside the pressure steam  sterilization package , when reaching certain sterilization conditions 121℃, 20 minutes or 132℃, 3 minutes, the chemical indicating stripe on the back base of wrinkled paper will change from light yellow to black.   USES:   1. Used to mark whether the package has been treated by pressure steam sterilization process.   2. If the discoloration is uneven or incomplete, it may indicate that the package has not been sterilized in accordance with the conditions.   3, wrap the parcel (if no sealing tape is used).   4, sterilization information can be recorded (operator, sterilization period, item name, pot, etc.).   Chemical instruction card for...
1 条评论
阅读全文