Service background
In the process of drug production, chemicals can enter into the drug from any material surface in contact with the drug and its components. Especially for biological drugs, some of their own non hazardous extracts may also change the way of action of biological drugs, thus changing the efficacy or generating new risk substances. The purpose of extractable and leachable Research (E & L) is to ensure that substances with potential safety risks do not enter the drug. In recent years, the medical accidents related to drug packaging materials are even more important to alert the medical people.
The structure of SUS is complex, the composition materials are diverse, the leachability trend is higher than that of traditional stainless steel, at the same time, a variety of SUS components are shared by a variety of process solutions, and how to design an economic and effective research program, etc., which brings many difficulties and challenges to the research on the extractable and leachables of SUS.
service content
To integrate the preliminary research information of the SUS components that the customers need to carry out extractive and extractive research, and collect the relevant material composition and production process. Based on the chemical composition and parameter information, contact conditions, sterilization methods and conditions, research purposes and other information of process pharmaceutical solution contacting with sus components, deep light design and carry out extractive research, methodological validation, extractive research, toxicological evaluation, and provide customers with comprehensive and systematic data that can meet the requirements of internal research or application of CFDA, FDA, emda and other laws and regulations Integrity of extractable and leachable materials.
Solution
Based on the technical guidelines for compatibility research of chemical injection and pharmaceutical glass packaging containers, technical guidelines for compatibility research of chemical injection and plastic packaging materials, technical guidelines for compatibility research of chemical injection and elastomer seals, UPS, USP, USP, USP, PDA of injection drug association TR66, the collection of application and technical documents of foreign pharmaceutical disposable system, and the research results of recent industry academic journals; at the same time, Shanghai Shenzhen Optical Co., Ltd. of China actively cooperates with New Jersey Shenzhen Optical Co., Ltd. of the United States and Wiesbaden Shenzhen Optical Co., Ltd. of Germany to keep up with the international industry progress, carry out internal research and technical improvement, and meet the increasingly high industry standards.
Our strengths
1、 The operation of deep light life science laboratory is in accordance with the highest quality standard (cGMP & ISO 17025), and has passed the review of the US Food and Drug Administration (FDA) and local regulatory agencies.
2、 More than 10 years experience in E & L research and testing.
3、 The E & L project team and E & L test team have many doctors and masters studying abroad, as well as doctors, masters and bachelors from top universities in China, with rich experience and team specialty.
4、 It has the top domestic analytical equipment, such as: uplc-q-tof-msms, uplc-dad-msms, uplc-dad-ms, GC-FID / MS, hs-gc-ms, ICP-MS, ICP-OES, c-npd, onic chromotagrpay, etc.
5、 Provide professional quality control testing services to help customers around the world to shorten the drug and medical device marketing cycle and ensure drug quality and safety.
