What are the differences between

GMP vs cGMP vs ISO Cleanrooms ?

I.What is GMP Validation Service?
Definition of GMP Cleanroom Validation Services:
GMP cleanroom validation service refers to a series of activities that conducts comprehensive inspection, testing and evaluation of the design, installation, operation and performance of cleanrooms in accordance with relevant laws and regulations such as Good Manufacturing Practice (GMP) to ensure that the cleanrooms can continuously and stably meet the environmental cleanliness requirements of related industries such as pharmaceutical production. The verification includes confirming the normal operation of the cleanroom's air purification system, air conditioning system, water supply and drainage system, electrical system and other facilities and equipment, and that environmental parameters such as dust particles, microorganisms, temperature and humidity, and pressure difference meet the specified standards.

II.Airkey™ Available GMP cleanroom services and processes
(1)Service Content
①　Design Consulting Services: According to the customer's production process and product requirements, we provide cleanroom design solutions, including layout planning, airflow organization design, purification level determination, etc.
②　Construction and installation services: Carry out cleanroom construction according to the design plan, including purification decoration, equipment installation, pipeline laying and other work, to ensure that the construction quality meets GMP standards
③　Testing and Verification Services：Carry out comprehensive testing and verification of the completed cleanroom, including air cleanliness testing, microbial testing, temperature and humidity testing, pressure difference testing, etc., and issue a detailed test report.
④　Maintenance service：Provide regular maintenance services for cleanrooms, including equipment inspection, filter replacement, cleaning and disinfection, to ensure the long-term and stable operation of the cleanrooms.

(2)General process
①　Project Negotiation: Communicate with customers to understand their needs and expectations for cleanrooms, and introduce service content and advantages.
②　Drawing Design：According to customer needs and relevant standards, we design cleanroom solutions, including floor plan layout, system configuration, etc., and submit them to customers for review.
③　Contract Signing：The two parties reached an agreement on service content, price, construction period and other matters and signed a contract.
④　Construction and installation：Carry out cleanroom construction and equipment installation according to the design drawing and construction specifications.
⑤　Debugging and testing：After the construction is completed, the system is debugged and various indicators are tested to ensure that the cleanroom meets the design requirements.
⑥　Verification：Verify according to GMP and other standards, issue verification reports, and deliver them to customers for use.
⑦　After-sales service：Provide regular maintenance and technical support to solve problems that arise during use.

III. Why is GMP cleanroom qualification necessary？
①　Ensure product quality：Products such as medicines have strict requirements on the production environment. Cleanroom certification can ensure the cleanliness of the production environment, prevent microorganisms and particulates from contaminating the products, and ensure the safety, effectiveness and stability of the products.
②　Comply with regulatory requirements：GMP and other regulations require that the cleanrooms of pharmaceutical manufacturers must meet corresponding cleanliness standards. Passing the appraisal is a necessary condition for companies to produce in compliance and avoid facing penalties for violations.
③　Protecting personnel health：In industries such as medicine, if the cleanroom environment does not meet the standards, it may lead to the spread of harmful microorganisms or chemicals, causing harm to the health of operators. Identification can ensure the safety of the working environment for personnel.
④　Improve enterprise competitiveness：Having a cleanroom that meets the standards can improve product quality and production efficiency, enhance the company's competitiveness in the market, and establish a good corporate image.

IV. GMP cleanroom identification and verification cycle
(1)Identification cycle
①　Newly built or renovated cleanrooms generally undergo the first inspection after completion, and all inspection items must be completed before being put into use to ensure that they meet the requirements.
(2)Verification cycle
①　Daily verification：For key parameters such as dust particles, microorganisms, etc., monitoring and verification are usually carried out weekly or daily.
②　Regular verification：Generally, a comprehensive revalidation is carried out every year or every two years to retest and evaluate the various performance indicators of the cleanroom.
③　Special situation verification：When there are major changes to the cleanroom process, equipment, layout, etc., or when product quality issues arise that may be related to the cleanroom environment, timely verification is required.

V. GMP cleanroom commissioning
①　Air volume debugging：By adjusting the fan frequency, air valve opening, etc., ensure that the total air volume, air volume at each air outlet and fresh air volume in the cleanroom meet the design requirements.
②　Pressure difference debugging：Check and adjust the pressure difference between the cleanroom and adjacent areas and rooms of different cleanliness levels to ensure that the airflow flows from areas with high cleanliness to areas with low cleanliness.
③　Temperature and humidity debugging: Adjust the cooling, heating, humidification and dehumidification functions of the air-conditioning system to ensure that the temperature and relative humidity in the cleanroom are within the specified range.
④　Airflow pattern debugging：Use methods such as smoke generation and hanging wires to observe the direction and pattern of airflow to ensure that the airflow is evenly distributed without eddies and dead corners.
⑤　Self-cleaning time debugging：Simulate the contamination of the cleanroom and test the time required for the air purification system to restore the cleanroom to the specified cleanliness.

VI. Risk Assessment in GMP Cleanrooms
①　Personnel risk assessment：Evaluate the impact of personnel's behavior, clothing, and operations when entering the cleanroom on the cleanroom environment, such as dust generated by personnel walking, pollution caused by improper operations, etc.
②　Equipment risk assessment：Analyze the risks that may arise from equipment selection, installation, operation, and maintenance, such as particles generated by equipment failure and microbial growth caused by incomplete equipment cleaning.
③　Material risk assessment：Conduct risk assessments on the transportation, storage, and delivery of raw materials, auxiliary materials, packaging materials, and other materials entering the cleanroom to prevent materials from carrying contaminants into the cleanroom.
④　Process risk assessment：According to the characteristics and requirements of the production process, evaluate the impact of dust, heat, humidity, etc. generated during the process on the cleanroom environment, as well as the risks that may be caused by process changes.
⑤　Environmental Risk Assessment：Consider the environmental factors around the cleanroom, such as the impact of external air quality and surrounding pollution sources on the cleanroom, as well as the risks that may be caused by fluctuations in environmental parameters such as temperature, humidity, and pressure difference within the cleanroom.
 

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