Mold making - Gerresheimer

High-performance injection molds for use in the clean room

Mold making Clean room mold Injection molding — Injection molding tool in the clean room according to ISO 14644-1 ISO class 8 with four ejector sides

Our high-cavity series molds are designed for the high output quantities and sophisticated quality requirements of the pharmaceuticals and health care industries. The molds are produced clean room-compatibly for stainless steel. Needle sealing nozzles exclude the formation of threads and thus of particle formation during demolding. The good ventilation of the molded part in the cavities prevents sedimentations that can also come loose in the form of particles. A glide-promoting coating of all movable parts in the mold ensures that no lubricant needs to be used. Adequate demolding angles ensure clean part demolding and avoid abrasion.

Most modern mold technologies

Mold making Multi-component molds Insert molding — Multi-component mold in the clean room according to ISO 14644-1 ISO class 8 for the insert molding of 0.3 mm needles

More than 65 specially trained employees produce single-cavity and multi-cavity injection molds with up to 128 cavities, tools for insert molding, indexing plate molds, stack molds, micro-precision molds, rotary table molds and hot-runner injection molds. Our molds are structured modularly and standardized. Exchangeable mold inserts ensure short waiting and repair times without additional adjustment work.

Uncompromising quality assurance

Mold making Micro-precision Injection mold — The most modern measurement materials, for example, CNC image processing measurement machines are used for internal mold making

The manufacture of our molds involves the use of the most modern vertical and wire eroding systems, precision grinding machines for all processes and micro-HSC milling machines. Uncompromising quality assurance is the highest priority in the entire production process. Precision molds are ultimately the prerequisite for excellent product quality. This is why only the most modern measuring equipment, for example, CNC image processing measuring machines, are used in the internal measurement lab of Gerresheimer Werkzeugbau Wackersdorf GmbH.

Qualification of molds according to defined SOP's in accordance with GMP and customer requirements

According to the rules of Good Manufacturing Practice (GMP), qualification and validation of the injection molding tools are necessary in every phase of the development and industrialization process.

This starts with the Design Qualification (is the mold design capable of manufacturing the specified products?), through Installation Qualification (does the realized mold correspond with the design?), Operational Qualification (do the products manufactured with the mold comply with specifications?) and finally Performance Qualification, during which the mold is commissioned under production conditions in order to prove that stable series operation is possible with the mold. The qualification service of mold makers often ends with Operational Qualification.

The functional capability of the mold is thereby checked on an injection mold machine of the mold maker, which is in most cases not identical with the machine used later for production. The ambient conditions are also different than those of series production.

Thus, for example, testing doesn't take place under the clean room conditions subsequently prevailing. The consequences are requalifications of the mold that cost time and money after transfer to the production location.

Gerresheimer, on the other hand, offers an integrated qualification and validation process that covers all phases of Design Qualification extending to Performance Qualification. Operational Qualification and Performance Qualification thereby take place under real conditions on the corresponding injection mold machine and in the corresponding production environment.

The question of the economic efficiency of the planned scope of qualification is of course posed. Not everything that is technically feasible makes sense for a product, a field of usage or a regulatory requirement level. Gerresheimer therefore offers three different qualification levels.

Level S Prototyp
Prototyping
Functional samples
Product development
If the mold is only required for the production of a prototype, for example, qualification for level S is adequate, at which only a Design Qualification and a part of the Operational Qualification is carried out. This is an especially fast, affordable solution for manufacturing products for functional testing in the development process. However, the use of these products in clinical tests on humans is not permitted!
Level Standard
Prototyping
Functional samples
Product development
Molds for clinical tests or series production require complete qualification according to the Gerresheimer level Standard, at which the Site Acceptance Test (SAT Run) and, in the case of transfer scenarios, also the Factory Acceptance Test (FAT Run) on the basis of the mean process parameters are carried out.
Level Standard Plus
Clinical samples
Series production
If the product is especially complex, the potential risk of use high or the regulatory environment especially sophisticated, for example, in the USA or Japan, it makes sense to carry out qualification according to the Gerresheimer level STANDARD PLUS. In the process, the SAT Run and possibly also the FAT Run are also carried out with the maximum and minimum parameters of the process window.

Prizewinning mold making

Mold making Micro-precision Injection molds — Technical Competence Center mold maker of the year 2014

Our mold making department is held to be among the best in the German-speaking world. This is documented by the top placement in the renowned competition "Excellence in Production", in which the Gerresheimer Werkzeugbau Wackersdorf GmbH took first place in 2009 and 2011 in the category "Internal mold making with up to 100 employees“. In 2014, the Technical Competence Center of Gerresheimer Regensburg GmbH even took first place and thus became “mold maker of the year 2014".

Technical Center

Technology center — Cavity pressure measurement in the technical center in Wackersdorf

The technical center of the TCC is our practice-oriented competence center for matters of injection molding. Molds and special-purpose machinery are subjected here to comprehensive application and processing tests under close-to-series production conditions and brought to series-production readiness. The sampling and mold optimization process in the technical center forms the basis of the entire component verification. Important stages of this process include the creation of a stable configuration setting for injection molding and comprehensive component measurement documented in an extensive initial sample test report. Machine and process-capability documentation and mold trials over defined periods of time (e.g. 4 or 24-hour runs) complete the technical center phase.

Your PLUS with Gerresheimer