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Project requirements for the new factory building 1. General principles The design should be technical, economical and applicable, ensure quality, and meet the requirements of energy saving, labor hygiene and environmental protection. 2. Air cleanliness level The cleanliness of the SMT room in the production pharmaceutical cleanroom refers to the 1,000,000-level requirements, and other places participate in the requirements for clean electronic workshops. 3. Overall design 3.1 The location selection and overall layout of the should be in an area with low atmospheric dust concentration and a good natural environment; away from traffic arteries and factories, silos, storage yards, etc. that emit a large amount of dust and harmful gases. Areas with severe air pollution, vibration or noise interference, with no obvious vibration sources around. Meet the requirements of fire protection and 14001. 3.2 Comprehensive coordination of process layout and design 1. The process layout is reasonable and compact, and the equipment layout conforms to the processing flow; 2. The main production equipment includes: AI, SMT, automatic production line of automotive electronics, PVC belt line, wave soldering machine; main test equipment There are: high temperature room, vibration table, high and low temperature box, test network room, drop shock table, etc. 3. The production pharmaceutical cleanroom requires stable temperature and humidity, good cleanliness, and convenient lighting and ventilation. 4. Consider the transportation route for the installation and maintenance of large-scale equipment, and reserve the equipment installation port and maintenance port. The equipment is abh\: 251.8M 5. The layout of the equipment and technology refers to the 'Plan of the Second Floor of the Main Plant' and 'Plan of the First Floor of the Main Plant'. 3.3 Personnel purification and material purification workshops shall set up personnel changing shoes at the upper stairs on the first floor. Clothing room and drinking water area, material purification rooms and facilities shall be set up at the entrance of the SMT pharmaceutical cleanroom, and living facilities shall be set up according to the requirements of the 'pharmaceutical cleanroom Design Specification'. room and other rooms. Personnel purification room should include rain gear storage room, management room, shoe changing room, coat storage room, toilet, clean work clothes room and air shower room, etc. Toilets, shower rooms, lounges and other living rooms, as well as other rooms such as work clothes washing rooms and drying rooms, will be set up in the second-phase decoration design according to the needs of the production process. The design of the personnel purification room and the living room should meet the following requirements: 1. A shoe cleaner should be installed at the entrance of the personnel purification room. 2. The coat room and the clean work clothes room should be set up separately. Clothes storage wardrobes and clean work clothes cabinets should be set up according to the design number of people. 3. Washrooms should be equipped with hand washing and drying facilities. One faucet should be set for every 10 people in the shift. 4. Toilets are not allowed in clean areas. The toilet in the room for personnel purification shall be provided with a front room. 5. Consider setting up air-air shower room tin. The air shower room should be located at the entrance of the personnel in the clean area, and should be adjacent to the clean work clothes room. A single air shower room is set up for every 30 people in the large class. When it is only a class 100 vertical laminar flow clean room, the airlock room can be changed. 6. SMT requires positive pressure management, and the pressure difference is 10~15Pa. When there are more than 5 staff in the clean area, a bypass door should be installed on one side of the air shower room. The pedestrian flow route should avoid reciprocating crossing. The layout of the personnel purification room and the living room is generally arranged according to the personnel purification procedure. The building area of u200bu200bpersonnel purification room and living room is calculated according to the average number of people in the clean area of u200bu200b4 to 6 square meters per person. In clean work clothes, there should be certain requirements for air purification. The equipment and material entrances and exits of the clean room should be set up according to the nature and shape of the equipment and materials, and the material purification room and its facilities should be set up. The arrangement of the material purification chamber should prevent the purified material from being polluted during the transfer process. 4.4 Noise control The noise level in the clean room should meet the following requirements: 1. During the dynamic test, the noise level in the clean room should not exceed 70 dBA. 2. During the empty state test, the noise level of the turbulent clean room should not be greater than 60 dBA; the noise level of the laminar flow clean room should not be greater than 65 dBA.
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Introduction

ISO 8 guidelines play a crucial role in maintaining sterile environments in various industries, including pharmacies. These guidelines ensure that pharmacies adhere to strict standards when handling medications and compounded preparations. By implementing cleanroom ISO 8 guidelines, pharmacies can minimize the risk of contamination and improve the quality and safety of their products.

In this article, we will explore the significance of cleanroom ISO 8 guidelines in pharmacies and how they are implemented. We will delve into the various aspects of these guidelines, from the requirements for cleanroom design and pharma machinery to the necessary procedures and training for pharmacy staff. Let us delve into the details of each aspect to gain a comprehensive understanding of meeting cleanroom ISO 8 guidelines in pharmacies.

The Importance of ISO 8 Guidelines

ISO 8 guidelines are essential to pharmacies as they help maintain a controlled environment in which medications, especially sterile compounded preparations, are prepared. These guidelines ensure that pharmacies comply with specific standards to minimize the risk of contamination during the compounding and dispensing processes.

By implementing cleanroom ISO 8 guidelines, pharmacies can improve both patient safety and medication efficacy. Sterile preparations, such as injectable medications, intravenous solutions, and ophthalmic products, require a sterile environment to prevent the introduction of harmful microorganisms, particulate matter, or other contaminants that could compromise their quality and safety.

Design and Layout of Cleanrooms

The design and layout of cleanrooms in pharmacies are critical factors in meeting cleanroom ISO 8 guidelines. Cleanrooms should be specifically designed to maintain cleanliness and control environmental conditions. Here are some key considerations:

Proper Layout: Cleanrooms should be designed with a logical flow to minimize cross-contamination and ensure efficient workflows. Separate areas for different processes, such as compounding, packaging, and storage, should be clearly demarcated.

Controlled Ventilation: Cleanrooms should have proper ventilation systems that maintain positive pressure, filtered air supply, and controlled air exchanges. The airflow should be designed to minimize the risk of contaminants entering critical areas.

Material Compatibility: The materials used in cleanroom construction should be compatible with the requirements of pharmaceutical operations. This includes the flooring, walls, ceilings, and fixtures. Seamless and non-porous surfaces are crucial to prevent the accumulation of contaminants.

Appropriate for Cleanrooms

To meet cleanroom ISO 8 guidelines, pharmacies must equip their cleanrooms with suitable devices and equipment. Here are some key considerations when selecting cleanroom equipment:

HEPA Filters: High-Efficiency Particulate Air (HEPA) filters are essential components of cleanrooms. They remove submicron particles from the air, ensuring the quality and cleanliness of the environment. Cleanrooms should have HEPA filters installed in the ventilation system and appropriate locations.

Pass-Through Chambers: Pass-through chambers facilitate the transfer of materials into and out of cleanrooms while maintaining the integrity of the controlled environment. These chambers should have appropriate airflow systems to prevent contamination during transfer.

UV-C Light: Ultraviolet-C (UV-C) light can be incorporated into cleanrooms to help reduce microbial contamination. UV-C light has germicidal properties and can be used in conjunction with other disinfection methods to ensure a clean environment.

Cleaning and Disinfection Procedures

Maintaining cleanliness and minimizing the risk of contamination in cleanrooms requires robust cleaning and disinfection procedures. Here are some key aspects to consider:

Surface Cleaning: surfaces, including floors, walls, countertops, and equipment, should be regularly cleaned using appropriate cleaning agents. -compatible disinfectants should be used to eliminate microorganisms effectively.

Proper Cleaning Techniques: Cleaning should be performed using validated techniques, such as wipe sampling, to ensure efficient removal of contaminants. Staff should receive thorough training on proper cleaning procedures and the use of cleaning agents.

Disinfection: Cleanrooms should undergo routine disinfection to eliminate any residual microorganisms. Disinfection protocols should be strictly followed, and appropriate disinfectants should be selected based on their efficacy against a wide range of microorganisms.

Training and Qualification of Personnel

Personnel involved in cleanroom operations should receive comprehensive training and qualification to maintain cleanroom ISO 8 guidelines. Some important aspects to consider include:

Behavior: Staff should be trained on the proper behavior and conduct expected within a cleanroom environment. This includes hand hygiene practices, personal protective pharma machinery (PPE) usage, and avoidance of behaviors that may introduce contaminants.

Standard Operating Procedures: Clear and concise standard operating procedures (SOPs) should be developed and implemented for all cleanroom processes. Personnel should be trained on these procedures to ensure consistency and adherence.

Continuous Training: personnel should undergo regular training and competency assessments to update their knowledge and skills. This ensures that they stay current with best practices and are aware of any changes in guidelines or regulations.

Summary

Meeting cleanroom ISO 8 guidelines in pharmacies is paramount to ensure the quality and safety of compounded medications. These guidelines outline specific requirements for cleanroom design, equipment, cleaning procedures, and personnel training. By adhering to these guidelines, pharmacies can minimize the risk of contamination and enhance patient safety.

Pharmacies must invest in the proper design and layout of cleanrooms, ensuring controlled environments that minimize the introduction of contaminants. Equally important is the selection of appropriate pharma machinery, including HEPA filters, pass-through chambers, and UV-C light, to maintain cleanliness and prevent contamination.

Cleaning and disinfection procedures should be robustly implemented, ensuring the regular and effective removal of contaminants. Personnel involved in cleanroom operations should receive thorough training and ongoing qualification to ensure compliance with cleanroom ISO 8 guidelines.

In conclusion, by prioritizing adherence to cleanroom ISO 8 guidelines, pharmacies can guarantee the sterility and quality of their compounded medications. The implementation of these guidelines is an investment in patient safety and effective healthcare delivery.

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