[Abstract] I believe that for most people who are engaged in packaging related work, & ldquo; packaging process validation & rdquo; should be a very strange term, because it is not a theoretical vocabulary, so it is not used in textbooks of general universities or vocational and technical schools.
Packaging process validation
I believe that for most people engaged in packaging related work, "packaging process validation" should be a very strange term, because it is not a theoretical vocabulary, so there is no such term in textbooks of general universities or vocational and technical schools. To be exact, apart from the attribute of "packaging technology", the "validation" itself should be a typical vocabulary of fine research and research in the industrial field. The common industrial fields include it semiconductor industry, pharmaceutical industry and medical device industry. It can be seen from this that & ldquo; Verification & rdquo; is a rigorous word, which is applied to some industries with very high requirements for process safety and stability. The packaging industry has not always been a very sensitive industry to safety or stability, so there are few people in the industry who know & ldquo; Verification & rdquo. However, when considering the combination of packaging and its inner packaging, Chinese printing enterprises are strong, and the packaging plays a decisive role in the requirements of packaging. MDSP mentioned in this paper is one of the typical ones.
Let's first look at the relevant standards and regulations on MDSP process validation. The first is ISO13485-2003, which is a comprehensive quality management system specially applied to the medical device manufacturing industry and inherits the general quality management system such as ISO9001. It clearly stipulates that those processes which cannot be confirmed by subsequent monitoring and measurement in the production or service process must be verified, operated and managed, but only included in the production It is obvious that packaging heat sealing process and sterilization process are the two most typical processes that need to be verified after the delivery of products or services, because they can not be confirmed whether they meet the expected design requirements by means of subsequent monitoring or measurement, and can only be finally confirmed whether there is a problem at the moment when the products or services are used.
Next, take a look at the offset printing of CE certification in the EU medical device directive, which clearly stipulates that the process validation report such as packaging and sterilization, together with product technical drawings, specifications and other documents, is an essential part of the CE technical documents. In other words, to obtain CE certification, packaging process validation is essential. Of course, this may not be the case. For example, you have a series of products. According to the requirements of iso11607-2006, you can choose one of the most challenging products, such as the heaviest, the largest size, and the sharp protruding parts, and verify the policies and regulations of packaging process. Then, use a written document to describe the combination of the most challenging products you choose Physical and chemical reasons, and filed as part of the validation report, can prove that this series of products are packaging validation.
Iso11607-2006 mentioned above is also related to MDSP process validation, and it is also the most direct and detailed standard on MDSP process validation. The second part clearly specifies that the manufacturers of pre formed sterile barrier system (PSBs) and sterile barrier system (SBS) should verify the necessary heat sealing process in their production process. However, unfortunately, offset printing, at present, the domestic medical device packaging suppliers have not carried out systematic verification of the necessary heat sealing process in the production process, and the relevant knowledge and training are also very lacking.
Although the above three regulations stipulate the necessity of MDSP process validation, the concept of MDSP process validation given by these standards is still difficult for ordinary people to understand. Broadly speaking, the process validation is interpreted as a documented process, that is, the process of documenting the factors and information related to the continuous stability of product packaging quality and forming the validation report. According to the explanation given in a document entitled "process validation guidance" issued in 2004 by the global harmonization task force (GHTF), which is mainly responsible for the harmonization and coordination of standards and regulations of medical devices in developed countries and regions such as Europe, the United States, Japan and Australia, the validation process is a process flow assurance It is a continuous and stable plan, but at last, it is necessary to submit a verification report manufacturer's information in a very systematic way in the form of documents, and there are relevant experimental data to support this report. Of course, this document of GHTF is suitable for many processes used in the production of medical devices, such as sterilization, injection molding, etc., not only for packaging process, but also recommended by FDA as a reference for process validation of medical device manufacturers.
At this point, the author needs to clarify two concepts that are easily confused in the domestic industry, because they involve the issue of equivalent translation between Chinese and English. The first is verification. Literal translation means "confirmation and verification". It is a concept with small scope and weak strength. It can be used to prove that a design meets the expected requirements with simple data, experiments or drawings, such as the actual heat sealing strength data of the sample to prove that it meets the expected range. The second is the validation network publishing, which is based on It is the "verification" mentioned in this article. It is a model