Jiwei has worked hard in the field of pharmaceutic

2022-08-16
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Ji Wei: worked hard in the field of pharmaceutical packaging materials testing

Ji Wei has been the director of Shanghai food and drug packaging materials testing institute since 1996 and was elected vice president of China Pharmaceutical Packaging Association in 2000

over the past 13 years, with his keen professional insight and high work passion, he has worked hard in the field of medical package material testing, created a laboratory with advanced facilities, leading equipment and standardized management, built a scientific and technological team with exquisite technology, high level and pioneering innovation, provided solid technical support for the government's scientific supervision, and contributed to the development of packaging industry

I. create laboratories with advanced facilities, leading equipment and standardized management

the drug administration law of the people's Republic of China and the measures for the administration of packaging materials and containers in direct contact with drugs were promulgated and implemented, which put the drug packaging management on track, and the packaging material inspection machine constitutes a key department for product quality control

with the support of his superiors, Ji Wei inspected and investigated the FDA, TGA, SGS and other international advanced laboratories, combined with the actual situation in China, and created a new Shanghai food and drug packaging length of 40mm two cylinder material testing institute with the concept of scientific development

1. Establish hardware advantages, develop characteristic testing

3000 square meters of single building experimental building, specializing in packaging material testing and clean environment testing. The chemical laboratory is designed with brand-new style, which embodies the principle of people-oriented; The material laboratory is equipped with independent constant temperature and humidity control to meet the specific environmental conditions of material test; The clean room is equipped with a real-time monitoring system, which improves the reliability and traceability of microbial experiments

more than 5 million instruments and equipment have been invested successively, so that the detection capacity covers all projects of packaging material standards, among which the detection means of large and medium-sized instruments have reached the international advanced level. In particular, the barrier performance testing instrument, which brings together a variety of international brands, can be applied to different methods and requirements of domestic and international standards. It can not only measure the oxygen or water vapor transmission of membrane materials, but also measure formed packaging products. A large-scale constant temperature and humidity box can carry out tests of compatible protective devices under different conditions, such as overcurrent, overvoltage, overload, etc; The micro infrared spectrometer can accurately analyze the structural components of multilayer coextrusion films; Plasma emission spectrometer, flame and graphite furnace atomic absorption spectrometer constitute a hierarchical metal element analysis platform; Liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry are effective means for qualitative and quantitative determination of unknown solvent residues in packaging materials

the cleaning detection instrument forms a series, and the laser particle counter of various particle size channels can meet the requirements of different cleaning levels; Two multi-point thermometers of international top brands are specially used for GMP verification of air purification system and its process water, gas and sterilizer; The vibration analyzer extends the test of biosafety cabinet; Aerosol scanner opens up leak detection test of high efficiency filter

the absolute advantages of hardware equipment and unique testing capabilities make our institute one of the most popular in China. It has not only become a subcontracting Laboratory for many domestic testing stations, but also attracted foreign well-known enterprises to cooperate one after another, with customers all over the country and going to the world

2. Keep pace with the times and improve management level

Shanghai food and drug packaging materials testing institute has been authorized to measure packaging materials and clean testing projects since 1993. In 2001, under the leadership of director Ji, it passed the laboratory accreditation (the first in the pharmaceutical industry). In 2005, as a designated unit of the Ministry of agriculture, it carried out GMP cleanliness testing of veterinary drugs; In 2006, it obtained the qualification approval of national medical device testing institution

Shanghai food and drug packaging materials testing institute shall participate in the domestic and international capability verification and comparison at least once a year to inspect and assess the overall testing capability level of the Institute. Since 2004, I have participated in the ability verification, and the results are satisfactory. In the laboratory, quality control activities such as personnel comparison test and sample retest are carried out every year to maintain the stability and reliability of testing quality

the self-developed LIMS system in the Institute is put into operation, the samples are managed by bar and line codes, and the on-site detection data and instrument test atlas can be directly imported into the original record module, realizing the whole process of automatic program management from sample acceptance, detection and test to report issuance, audit and approval. Sample library management and reporting business accounts are included in the system, and information resources can be shared. Thus, human errors are reduced, the reporting process is standardized, and the work efficiency is improved. We have also opened the entrustment and inquiry business to facilitate customers' remote inspection. The office automation system is adopted to realize the networking and paperless daily management

second, we have built a scientific and technological team with exquisite technology, high level and pioneering innovation.

Ji Wei is not satisfied with completing routine inspection work, but actively strives to participate in standard formulation and a large number of subject research, and has trained a scientific and technological team with exquisite technology, high level and innovation

1. Do a good job in inspection and provide technical services for government supervision

Ji Wei led the team to do a fair and scientific job in the supervision and sampling inspection of food and drug packaging materials and the product registration and inspection of drug packaging materials, and timely analyze and feed back the sampling results and market information to the superior competent departments, so as to provide reference basis for the government to formulate market monitoring plans. Also cooperate with the supervision to complete various surprise tasks, such as: quality inspection of hollow capsules; Safety performance inspection of implanted medical devices; Detection of organic solvent residues in plastic pipelines of large medical devices such as ventilators, cardiopulmonary machines, etc. Through a large number of experimental data to analyze and evaluate the safety of products, so that the government regulators have comprehensive information. He promised to open his service to the outside world, establish a window service specification internally, and required the Institute to be based in Shanghai and face the whole country to provide first-class testing services for packaging material testing stations and packaging material enterprises in various provinces and cities

as a technical expert, he also regularly participated in the national drug packaging material product registration and evaluation, and set a good technical gateway for the development of drug packaging material enterprises

2. Participate in the formulation of standards and lead the orderly development of the industry

as one of the main drafting units of drug packaging materials standards, Shanghai food and drug packaging materials testing institute participates in the preparation, revision, review and verification of national standards every year. As of 2008, 197 drug packaging materials standards have been prepared, revised, reviewed and verified, building a technical defense line for the quality control of drug packaging products. In this process, the inspectors are familiar with the production process and process of packaging materials, understand the feasibility and key points of the operation method, accumulate the experience of packaging material inspection, and improve the technical knowledge and ability. Subsequently, our institute sent business backbones to participate in the publicity and implementation tour of the National Bureau of pharmaceutical packaging materials standards, and conducted extensive training for national testing stations and packaging materials enterprises, which promoted the full implementation of the national standards for pharmaceutical packaging materials

Since 1994, Shanghai food and drug packaging materials testing institute has successively formulated the industry standard yy/t pharmaceutical clean room (area) suspended particle test method and the national standard gb/t16292 ~ pharmaceutical industry clean room (area) suspended particle, planktonic bacteria and settling bacteria test method. Ji Wei is the main drafter and the first drafter respectively. The two standards were rated as "excellent project of pharmaceutical standardization" by the State Pharmaceutical Administration in 1986 and 1988 respectively, and were awarded the first prize. As a result, the clean inspection business of Shanghai food and drug packaging materials testing institute has been standardized and developed, playing a benchmark role in leading the orderly progress of the industry

Ji Wei's command team drafted "requirements for clean room (area) of drug packaging material production", "guiding principles for clean room (area) testing of drug packaging production plant" and "verification guide for damp heat sterilizer and damp heat sterilization process" based on routine testing and GMP verification as a breakthrough point, with rich practical experience. Recently, gb/t16292 ~ 16294 "test methods for suspended particles, planktonic bacteria and settling bacteria in clean rooms (areas) of the pharmaceutical industry" has been upgraded and revised

3. Undertake subject research and carry out risk assessment of food and drug packaging

"Research on the compatibility of antibiotics and butyl rubber stopper" is a National Bureau subject undertaken by Shanghai food and drug packaging materials testing institute. Through a six-month experiment, nearly 20000 experimental data were statistically analyzed, and an 80000 word subject report was submitted, detailing the relationship and impact of rubber stopper on drug quality, It provides a technical basis for enterprises to reasonably select domestic new rubber plugs when the country eliminates natural rubber plugs. Recently, in order to further explore the root cause of the impact of rubber plugs on drugs, Shanghai food and drug packaging materials testing institute has gone deep into enterprise research and continued to carry out a new research topic

"food packaging safety research" and "DEHA migration in PVC fresh-keeping film" and "phenol migration in polycarbonate molded products" are the subject projects assigned by the food department of the State Administration for two years respectively. Shanghai food and drug packaging materials testing institute designed a rigorous experimental program. After being demonstrated by statistical experts, it conducted sampling inspection on supermarkets and wholesale markets in urban-rural areas in more than 30 provinces and cities across the country, carried out investigation and Analysis on the current situation of food packaging market, and made risk assessment and safety evaluation. When the society pays high attention to the safety of PVC fresh-keeping film, we have provided sufficient experimental data for the government spokesperson and done a solid technical support

Shanghai food and drug packaging materials testing institute participated in the project of Shanghai Science and Technology Commission to study the "impact of using RFID radio frequency tags on drug packaging". By estimating the amount of RF radiation that drugs may receive in the circulation process, simulate the radiation of drugs in the acceleration period, and conduct a large number of experiments on the quality of drugs after acceleration and simulated radiation according to the design scheme, and then analyze the possible impact of RF on drugs according to the test data. This topic is a preliminary research for the use of drug electronic labels

this year, it also participated in the key projects of the national science and technology support plan of the "Eleventh Five Year Plan" - pre clinical safety evaluation of new pharmaceutical excipients and safety research on the compatibility of drugs and packaging materials. Shanghai food and drug packaging materials testing institute undertook two sub topics, "Research on the formulation and technology of common drug packaging materials" and "Research on the impact of recycled plastics on drug safety". Through the establishment of safety formula and process, packaging enterprises with uneven production and technical levels will have a unified basis for production control, improve the overall level of production control, and ensure the safety of products from the source and production process

4. Strengthen technical cooperation to solve problems for enterprises

in order to study the impact of drug packaging on the safety and effectiveness of drugs, the discovery of Shanghai food and drugs is a very special answer sheet given by the Shanghai Institute of food and drugs in the face of the global anxiety about the supply and demand of rare earth materials. The packaging materials testing institute took the lead in carrying out the compatibility test between packaging materials and drugs in the country, The viewpoint of "qualified drugs + qualified packaging ≠ qualified products" is proved by a large number of experimental data. It provides technical guidance for enterprises to reasonably select drug packaging materials

Shanghai food and drug packaging materials testing institute cooperates with world-famous enterprises to carry out "infusion packaging adsorption research". The technical requirements of this project are rigorous, and the test content is complex. It is necessary to compare a variety of infusion packaging conditions at the same time to control various influencing factors. The successful completion of this research not only reflects the analytical strength to the foreign side, but also makes the foreign side have a better understanding of China's scientific research ability

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