Wackersdorf, October 2014: During the development phase, Quality by Design (QbD) systematically determines the quality of both the product and the production process. Strategically applied, Quality by Design is not only the most reliable, but also the most economic approach to introducing complex products to the market. Pharmaceutical and medical technology specialist Gerresheimer has been strategically applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market, which provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.
According to Good Manufacturing Practice, injection molds have to be qualified and validated during every phase of the development and industrialization process. This procedure is comprised of four stages: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Often, the qualification service of mold manufactures only includes some parts of this process. “Molds that are not inspected on the injection molding machine that is later used for large-scale production under real production conditions will have to undergo post-delivery requalification procedures. For the customer, this means additional cost and extra time”, Dr. Peter Mayr, Head of Quality Assurance Technical Competence Center, Gerresheimer Regensburg GmbH, Wackersdorf, explains. “Hence, Gerresheimer offers customers a complete and integrated qualification and validation process, which is carried out under real production conditions, on the actual injection molding machine and under relevant production conditions.” Part of this qualification process is the definition of a process window for a reliable production: Gerresheimer carries out a screening according to the SIM approach in order to determine the critical production parameters. A factorial Design of Experiments (DoE) – analyzed with Minitab, a program that was specially developed for quality-related applications – allows the determination of the process mean and the process limits for the production.
When some stages of the process – i.e. DQ and IQ – are carried out by Gerresheimer’s Technical Competence Center (TCC) and OQ and PQ are conducted at the envisaged production location, the overall qualification process becomes more cost-efficient and faster. This approach allows a seamless run of all qualification and validation processes without the need for requalification measures. For international projects, however, it may be better to carry out the predominant part of the qualification process on the development site and then relocating the injection molding machine complete with mold – or the mold itself – to the final production site afterwards. “We offer customers with global business activities two transfer scenarios, which involve a repetition of part of the OQ on the customer’s site in order to analyze the mold’s performance under different ambient conditions or on a different injection molding machine”, Michael Wiglenda, Director Technical Competence Center, Gerresheimer Regensburg, Wackersdorf, explains. “Our qualification service also offers different qualification levels, which are tailored to the customer’s project”. Molds that are only used for prototype production, for example, are perfectly covered by an “S level” qualification, which includes DQ and parts of the OQ. Molds for clinical tests or large-scale production require full qualification according to Gerresheimer’s “standard level”, which features qualification and validation based on the mean process parameters. For particularly complex products, a high potential deployment risk or complex-regulation markets Gerresheimer’s “PLUS level” qualification is the best option. In this option, test runs are carried out with maximum and minimum parameters of the process windows.