Clean room process hygiene management system

1. Purpose

This management system is specially formulated to effectively control the process hygiene management of clean room tooling and mold cleaning, material cleaning, operating table, site, wall, ceiling cleaning, cleaning and storage of cleaning tools, clean room (area) air disinfection, disinfectant selection, and use management.

(Figure 1: Clean room)

2. Scope

It is used for clean room process hygiene management.

3. Basis

This document is formulated in accordance with the "Medical Device Production Quality Management Specification" and "Clean Workshop Management Control Procedure".

(Figure 2: Clean room process hygiene management)

4. Procedure

4.1 Tooling and mold cleaning

4.1.1 Tooling and molds should be thoroughly cleaned and disinfected when used for the first time;

4.1.2 Clean once before each use and after production;

4.1.3 Tooling and molds should be cleaned with special rags and plastic brushes that do not shed fibers (use appropriate detergent when necessary), and purified water should be used for cleaning.

4.2 Material Cleaning

4.2.1 Materials that need to Enter the clean room should be unpacked outside the clean room, cleaned with a clean rag, and then stored in the material storage room to prepare for entering the clean room:

4.2.2 Materials and products to be packaged must be sent into the clean room through the transfer window after unpacking. Confirm that the inner and outer doors of the transfer window are interlocked and the UV light is effective before opening the door and quickly putting the items into the transfer window and closing it, and turning on the UV light. The items placed in the transfer window must stay in the transfer window for at least 5 minutes before they can be taken out of the transfer window, and the door and UV light must be closed.

4.3 Cleaning of operating tables, sites, walls and ceilings

4.3.1 Clean from top to bottom and from inside to outside. Always wipe in overlapping long straight lines instead of scraping in circles. Always clean from the cleanest area to the dirtiest area:

(Figure 3: Operating table)

4.3.2 Before and after production, use wet cleaning cloths, mops and other tools to remove dust and stains on the surface of operating tables, floors, doors and windows. Use brushes and detergents to scrub and remove dirt where dirt accumulates. Use disinfectants to disinfect when necessary:

4.3.3 Thoroughly clean and disinfect the clean area once a month (including disinfection of walls and ceilings).

4.4 Cleaning and storage of cleaning tools

4.4.1 Clean rags should be used in different categories, and all types of cleaning tools should be cleaned and disinfected in different categories.

4.4.2 Cleaning of rags: Soak in a basin containing 5% detergent for 5 minutes, gently rub and clean with your hands, take out and wring dry, and pour out the cleaning liquid in the basin, and rinse with drinking water.

Rinse twice with purified water, take out and wring dry, and let dry naturally.

4.4.3 Disinfection of rags: Wash and wring them according to 4.6.2, then soak them in a basin containing 75% ethanol solution or 0.2% chlorhexidine for 30 minutes, take them out and wring them out, and hang them on the sanitary ware rack in the tool cleaning room.

4.4.4 Cleaning of plastic brushes: Soak them in a basin containing 5% detergent for 5 minutes, then rinse them with purified water, store them in the tool cleaning room, and let them dry naturally.

4.4.5 When disinfecting plastic brushes, wash them according to 4.6.4, soak them in a basin containing 75% ethanol solution or 0.2% chlorhexidine for 30 minutes, take them out and shake them lightly over the basin mouth until no disinfectant drips, and store them in the tool cleaning room.

4.4.6 Cleaning of basins: First use a brush dipped in 5% detergent water to clean the inner and outer walls of the basin, then rinse them twice with purified water, drain them and store them in the tool cleaning room.

4.4.7 Basin disinfection: Clean according to 4.6.6, wipe the inner and outer walls with a mercerized towel dipped in 75% ethanol solution or 0.2% chlorhexidine, drain and store in the tool cleaning room.

4.4.8 Mop cleaning: First soak the mop in a cleaning basin containing 5% detergent for 3 minutes, wipe the handle with a mercerized towel dipped in 5% detergent until it is clean, rinse with drinking water, and then wash twice with purified water, drain and store on the sanitary ware rack in the tool cleaning room.

4.4.9 Mop disinfection: Clean according to 4.6.8, wipe the handle with a mercerized towel dipped in 75% ethanol solution or 0.2% chlorhexidine for disinfection, then soak the mop in 75% ethanol solution or 0.2% chlorhexidine for disinfection, drain and store on the sanitary ware rack in the tool cleaning room.

4.4.10 Clean area cleaning tools are cleaned once after each use.

4.4.11 Clean area cleaners are cleaned in the tool cleaning room.

(Figure 4: Clean room cleaning tools)

4.5 Strengthen disinfection once a month, and irradiate each area with ultraviolet light for 40 minutes.

4.6 Management of selection and use of disinfectants

4.6.1 Use 0.2% chlorhexidine and 75% ethanol for hand disinfection.

4.6.2 Use 75% ethanol, 0.2% chlorhexidine solution, and 3% hydrogen peroxide solution to disinfect the parts of the equipment that are in direct contact with the product, the surface of the operating table that is in direct contact with the product, the production tools that are in contact with the product, and some inner packaging materials;

4.6.3 Use 0.2% chlorhexidine solution and 75% ethanol to disinfect the indoor floor, walls, and ceiling.

4.6.4 Use 0.2% chlorhexidine solution and 75% ethanol to disinfect cleaning tools;

4.6.5 Use ultraviolet light for air disinfection;

4.6.6 The water used to prepare the disinfectant is purified water, and the use period after preparation is fifteen days.

4.6.7 Disinfectants in clean rooms are rotated monthly.

4.6.8 The wall of the container of the prepared disinfectant should be marked with the name, preparation date and other information, and all preparation and use should be recorded.