KN95 Masks For Coronavirus Protection
Product Dimesnion: 6.18" x 4.13" /15.70cmx10.50cm
Mask Fabric Material: 5-ply material,100% polypropelyne
Ear Loop Material: 70% polyamide, 30% elastane
when to use: suitable for adults to use daily in a variety of settings such as home, outdoors and work
packaging: 5 pcs of mask in one sealed printed plastic bag to ensure hygiene or 10pcs per box
certification/standard: GB2626-2006(China KN95 standard) and FDA registered
about the manufacturer: Kapanou is china-based healthcare company
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1. Manual cleaning mode: such as manual disassembly of filters, filter cartridges, hoses, etc., must be removed and washed to ensure the cleaning effect; it is an unstable treatment method, reproducibility and effectiveness can not be guaranteed, the quality risk level - "high".
2. Semi-automatic cleaning mode: Ultrasonic technology is used to clean the filter and other accessories; it is a relatively stable processing method, and the reproducibility and effectiveness can be basically guaranteed. The quality risk level is “ä¸ä¸â€.
3, fully automatic cleaning mode: the use of human-machine interface, information exchange and functional contact or mutual influence, to achieve a fixed process or procedures to complete the batching equipment or system operation; using CIP / SIP technology, basically have the following conditions : The name of the lotion and the concentration, temperature, flow rate and time of the lotion are used for cleaning purposes; it is a stable treatment method, and the reproducibility and effectiveness can be guaranteed. The quality risk level is “lowâ€.
development trend:
With the continuous improvement of drug quality risk control, the risk control of the batching system has reached the necessary execution level. The manual manual cleaning mode and the semi-automatic cleaning mode must be eliminated to reduce the harm of human error to the product, so the production system of the sterile preparation is used. In addition, the reliable online CIP/SIP function will be added to reduce or remove the substances remaining in the production equipment from the previous batch to the extent that it will not affect the quality and safety of the next batch of products, and can effectively remove the organic matter required for microbial reproduction. The microbial contamination is controlled at a certain level and can achieve the reproducibility and effectiveness required for verification.
First, the program operating system control scheme adopts human-machine interface (HMI) is an important central link in human-machine system: it refers to the field where people and equipment contact or interact with each other in information exchange and function, information exchange, functional contact or mutual Impact refers to the hard and soft contact between the person and the machine. The joint surface includes not only the direct contact of the dotted line, but also the space for information transmission and control over a long distance, and has multi-level password protection and automatic alarm function; The program control PLC performs predetermined process mode operations on the batching system hardware to achieve a stable operation mode to improve product quality and safety and reduce risks in the batching process.
Material system operation and cleaning schemes are different according to product or production process requirements. The production process and CIP/SIP process flow are required to refer to the production process; on the basis of ensuring the reproducibility and effectiveness of the operation and verification process, Fixed operating mode via HCI input:
1, production operation mode:
2, CIP rough wash mode:
3, CIP cycle cleaning mode:
4, CIP fine wash mode:
5, SIP sterilization mode:
6, data storage mode:
7, security alarm mode:
8, password protection mode:
The above various operation modes include production operation, cleaning processing, sterilization process, real-time monitoring, recording, alarm, password protection, etc., and online monitoring devices are provided at different control points of the material system to monitor and record the running status in real time. To ensure the effectiveness and safety of its operation.
In the production of pharmaceuticals, eliminating cross-contamination of active ingredients, eliminating foreign matter, insoluble particulates, reducing or eliminating the contamination of injectables by microorganisms and pyrogens is essential for ensuring the quality and safety of products; The cleaning method of the material system can be divided into three modes: manual, semi-automatic and fully automatic.