Gerresheimer Introduces Integrated Processes for Mold Qualification

October 30, 2014
Adeline Siew, PhD

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Gerresheimer, a company with expertise in pharmaceutical and medical technology, announced that it is applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market. The company notes that this approach provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.

A quality-by-design (QbD) approach places emphasis on the production process during development and its impact on product quality. Implementation of QbD has proven to be reliable and economic when it comes to commercializing complex products.

Gerresheimer, a company with expertise in pharmaceutical and medical technology, announced that it is applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market. The company notes that this approach provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.

Injection molds have to be qualified and validated during every phase of the development and industrialization process according to GMP guidelines. This procedure consists of four stages: design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). The qualification service of mold manufacturers, however, often 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, explained in a press statement. Gerresheimer’s approach is to offer a complete integrated qualification and validation process, which is performed under real production conditions, on the actual injection molding machine and under relevant production conditions, Mayr added.

The critical production parameters are determined so that a process window for reliable production can be defined. 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. Some stages, such as DQ and IQ, would be carried out at Gerresheimer’s Technical Competence Center (TCC), whereas OQ and PQ are conducted at the envisaged production location. According to Gerresheimer, this approach facilitates a faster and more cost-efficient process and allows a seamless run of qualification and validation without the need for requalification measures.

For international projects, Gerresheimer suggests carrying out the predominant part of the qualification process on the development site and then relocating the injection molding machine or the mold to the final production site later on.

The company offers two types of transfer arrangements, according to Michael Wiglenda, director, Technical Competence Center, Gerresheimer Regensburg, Wackersdorf—“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.”

Wiglenda also explained that different qualification levels are available and can be 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 recommends its “PLUS level” qualification, in which test runs are carried out with maximum and minimum parameters of the process windows.

Source: Gerresheimer