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The "Sealing Test Third Edition Standard" (SMEPAC) released by ISPE (International Association for Pharmaceutical Engineering) is recognized as an authoritative technical specification in the global pharmaceutical industry. This standard was jointly formulated by ISPE and global pharmaceutical engineering experts. The core writing team includes authoritative scholars in the fields of toxicology, industrial hygiene and compliance (such as Dr. Robert Sussman, Matthew Meiners, etc.), and integrates the compliance requirements of regulatory agencies such as the FDA and EMA. Its content covers the entire life cycle management, including test design, data statistics, and reporting standards. It is widely used in the validation of sterile drug production facilities and has become an important basis for enterprises to meet GMP regulations.
The third edition of ISPE SMEPAC, through technological iteration and feedback from industry practices, continuously leads the scientific and standardized process of pharmaceutical sealing verification. It is a cornerstone document for ensuring the quality of drugs and the safety of production personnel during the production process.
BEEREE, along with its partners and the core authors of the ISPE SMEPAC standard, Dr. Robert Sussman (Ph.D., DABT) and Matthew Meiners (CIH), and Dr. David Lu (CIH, CSP), the technical director of BEEREE, The three will jointly conduct an in-depth analysis of the update of the sealing test methodology in the third edition of the standard, the alternative material selection specifications (such as lactose, mannitol, etc.), and the compliance strategies for high-risk operation scenarios (such as the production of high-activity apis). Through this sharing, we will systematically grasp the guiding significance of the new version of the standard for equipment design, verification implementation and personnel protection, and help enterprises enhance the safety and compliance level of closed production.
The history of the ISPE SMEPAC test standard
The third edition of the standard has undergone changes in aspects such as test design strategies, data statistical analysis, and reporting requirements
The application and improvement directions of the ISPE SMEPAC test standard
ISPE SMEPAC Test Question and Answer session
Robert Sussman
Ph.D., DABT
Dr. Robert is a senior expert in the field of occupational health and safety risk assessment, holds a Ph.D. in environmental Health Science from New York University, and is qualified as a DABT (Certified Toxicologist of the American Society of Toxicology), SafeBridge Consultants, Inc. Managing Director He focuses on occupational health risk assessment, industrial hygiene and regulatory toxicology in the pharmaceutical industry. Skilled at integrating toxicological data with engineering control strategies, we provide risk management solutions for pharmaceutical enterprises that comply with regulations such as OSHA and NIOSH.
Dr. Robert's work involves chemical exposure assessment, hazard identification, and the formulation of occupational health policies. He participates in industry forums and technical training to promote scientific understanding of occupational exposure risks in the pharmaceutical industry.
Matthew Meiners
CIH
Matthew is a senior expert in the field of pharmaceuticals and industrial hygiene in the United States. He is a Certified Industrial Hygien (CIH) in the United States and works at SafeBridge Consultants, Inc., responsible for laboratory analysis services, method development and toxicological research in the pharmaceutical industry. He has approximately 40 years of experience in hygiene and analytical chemistry in the pharmaceutical industry, contract studies, toxicology and commercial development.
He is a member of the American Industrial Hygiene Association (AIHA), a member of the American Association of Pharmaceutical Scientists (AAPS), and a cooperative expert of the International Society for Pharmaceutical Engineering (ISPE). He has provided process optimization and occupational health risk assessment services for many multinational pharmaceutical companies, helping to reduce the risk of chemical exposure in the production process. He led the industry training on "Safety and Contamination Control in Pharmaceutical Laboratories" and developed protective plans for high-risk operations (such as API synthesis and formulation filling).
David Lü
Ph.D., CIH, CSP, PE
One of the founders and technical director of BEEREE Company, holds a Ph.D. in occupational Health from the United States and a master's and bachelor's degree in safety engineering from China. Hold the CIH and CSP certificates from the United States. He has been engaged in management, training and consulting in fields such as industrial safety, occupational health and labor efficacy for 30 years, including 15 years of study and work experience in the United States.
Dr. Lu has successfully completed hundreds of various EHS consulting and delivered on-the-ground solutions for clients in over 30 countries across North America, South America, Europe, Africa, Asia and other regions. In recent years, he has trained more than 3,000 people in English or Chinese in over 30 countries. Dr. Lu has independently authored or co-authored numerous scientific papers, technical reports and standards in the fields of environmental protection, occupational safety and industrial hygiene, EHS management manuals and procedures, etc.
Course consultation
Reservation of lectures
BEEREE was established in 2008 and has provided extensive HSE consulting, training and engineering services to customers in over 40 countries across Asia, Africa, Latin America, North America, Europe, the Middle East and other regions.
BEEREE adheres to strict international professional ethics standards. The senior team advisors have all obtained professional certificates from authoritative industry institutions in the United States and have global project delivery experience. BEEREE combines international certification standards and advanced technologies with a local perspective, dedicated to providing customized HSE solutions and value-added services that are cost-effective, effective and implementable for Fortune 500 companies, small and medium-sized enterprises and universities, ensuring the safety of workers, the public and the community.
Trinity Consultants & SafeBridge® was established in 1997 and has been committed to providing EHS consulting and laboratory analysis services for the pharmaceutical industry in North America and Europe for more than 20 years. Its consulting team is composed of toxicologists, industrial hygienists, chemists, and senior safety and environmental professionals in the pharmaceutical industry. The Control Banding/OEB tool that we are all familiar with was pioneered by them.
The star course of SafeBridge®, Potent Compound Safety Boot Camps (Highly Active Compound Safety Training), has been successfully held in countries and cities such as Shanghai and Wuxi in China, Raleigh, Chicago and Boston in the United States, Berlin in Germany, Liverpool in the United Kingdom, Santiago in Chile, and Hyderabad in India.
Address：Xiehe Yunchuang, No. 2 Xiyuan Fifth Road, Xihu District, Hangzhou
Telephone：0571-88391363
E-mail：henry.zhu@beeree.com
