In the field of pharmaceutical production, compliance and efficient operation have always been the key to the development of enterprises. In 2025, the GMP air conditioning system validation regulations have undergone a series of important changes, which pose new challenges to the environmental control of pharmaceutical production enterprises. Suzhou Yikang Environmental Testing Co., Ltd., as a professional third-party testing institution in the industry, provides comprehensive and accurate air conditioning system verification services for enterprises with its professional technical team and rich practical experience, helping enterprises cope with regulatory changes calmly and ensuring the stability and compliance of the production environment.

2025 yearGMPKey points of regulatory changes for air conditioning system verification

• Combining movement and stillness to strengthen the verification of airflow patterns：2025 year 3 The draft for soliciting opinions on the sterile drug appendix released this month clearly requires that the validation of airflow patterns in air conditioning systems should shift from traditional static validation to“Combining movement and stillness”The comprehensive evaluation model. This means that companies not only need to pay attention to the airflow distribution in static environments, but also need to deeply investigate the dynamic impact of operational interventions on airflow.Suzhou Yikang Environmental Testing Co., Ltd. is equipped with advanced visualization recording equipment that can accurately capture changes in airflow, establish a detailed dynamic simulation operation standard scene library for enterprises, ensure that the verification results truly reflect the actual production, and effectively assist enterprises in seamlessly applying the verification results to the production quality control system.

• Optimize the frequency of reconfirmation and accurately control the stability of the system：According to Appendix 1 of the EU GMP and the draft for soliciting opinions on sterile drugs in China, A/B level clean area air conditioning systems need to be reconfirmed every six months, while C/D level air conditioning systems need to be reconfirmed once a year.Suzhou Yikang Environmental Testing Co., Ltd. deeply understands the core essence of this regulatory change and abandons the traditional approach of relying solely on annual quality reviews to maintain verification status. Through professional periodic evaluations, it accurately controls the stability of the air conditioning system in different clean level areas. Our professional team will tailor differentiated verification plans for enterprises based on their actual production situation, pollution control strategies, and risk assessment results, ensuring compliance while reducing operational costs.

• Keeping up with industry standards and implementing new technical specifications：The "Construction and Acceptance Standards for Cleanrooms in the Pharmaceutical Industry" officially implemented from September 1, 2025, put forward clear requirements for the material of exposed air ducts and the commissioning and operation of purification air conditioning systems in pharmaceutical clean areasSuzhou Yikang Environmental Testing Co., Ltd. always pays attention to industry standard dynamics and integrates standard requirements into the verification service process as soon as possible. We strictly follow the standard regulations and conduct a detailed inspection of the material of the exposed air ducts to ensure compliance with the requirements of stainless steel material; At the same time, comprehensive debugging of the operation mode and control system of the purification air conditioning system is carried out to ensure that the system operating parameters have traceability and automatic adjustment functions, and to eliminate compliance risks caused by manual data recording from the source, which is beneficial for the enterpriseGMPThe system assessment provides a solid guarantee.

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Suzhou Yikang Environmental Testing Co., Ltd. Professional Service Advantages

• CMAQualification support, professional and reliableAs possessingCMASuzhou Yikang Environmental Testing Co., Ltd., a qualified third-party testing institution, has solid technical strength and strict quality control system. The testing report we provide has broad professionalism and credibility, and has been highly recognized both inside and outside the industry, providing strong endorsement for the compliant operation of enterprises.

• Comprehensive service coverage, one-stop solutionProvided by Suzhou Yikang Environmental Testing Co., LtdGMPCleanroom design confirmation（DQ）Installation confirmation（IQ）Operation confirmation（OQ）Performance confirmation（PQof4QRelated verification services, including clean room air volume, air exchange rate, pressure difference, high-efficiency filter leakage detection, cleanliness (suspended particles), temperature, relative humidity, illumination, noise, self-cleaning time, planktonic bacteria, settling bacteria, and surface microorganisms（ATheBTheCTheDVarious levels), compressed air quality testing (oil, water, particulate matter, microorganisms), air flow testing and other testing items, as well as purified water (Chinese Pharmacopoeia) 2020 Related tests such as version, ozone concentration, formaldehyde, as well as equipment tests such as biosafety cabinets, purification workbenches, transfer windows, laminar flow hoods, and isolators. Our one-stop service model can meet the diverse needs of enterprises in air conditioning system verification and production environment testing, saving them a lot of time and energy costs.

• Professional technical team, experiencedThe company has gathered a group of professional technical talents who have been deeply involved in the field of clean room testing and verification for many years. They are familiar with various domestic and foreign regulations and standards, have rich practical operation experience, and can provide personalized and accurate verification service solutions according to the specific situation of the enterprise. Whether it is complex airflow pattern verification or rigorous reconfirmation evaluation, our team can provide high-quality and efficient services for enterprises with professional skills.

face, confront 2025 yearGMPSuzhou Yikang Environmental Testing Co., Ltd. is willing to work hand in hand with pharmaceutical production enterprises to assist them in smoothly completing regulatory compliance upgrades with professional services, ensuring that the production environment always meets high standard requirements, and safeguarding drug quality and safety.

If you are interested in our services, please feel free to contact us at any time. We look forward to working with you to open a new chapter in compliance management for pharmaceutical production environments