CAQ-Software at GAPLAST - Cleanroom Quality

GAPLAST GmbH is an innovative developer and producer of packagings, applications, and disposable products for use in the pharmaceuticals, medical-technology, and cosmetics industry. Founded in the Bavarian town of Saulgrub-Altenau in 1969, the history of the company began with the development of an innovative sealing plug for tablet packaging.

Innovative and Certified

Today the company Gaplast GmbH, employs over 200 people at two production sites. Over the years it has developed a whole host of innovations and production techniques and has registered over 100 patents. Gaplast was first certified in accordance with the quality management standard DIN EN ISO 9001 in 1994 and achieved DIN EN ISO 15378 certification in 2016. This standard describes the particular quality management requirements for producers of primary packaging materials for medicinal products.

Cleanroom-Concept in Accordance with DIN EN ISO 14644

At the production site in Peiting that opened in 2012, clean-room injection moulding / injection blow moulding is performed in accordance with DIN EN ISO 14644-1 class 8. With great energy efficiency, so-called air shower boxes pass a laminar flow of clean air across the freshly produced products. If the customer requires so, the production site can also produce in accordance with clean-room class 6 by using specially encapsulated laminar-flow areas. All production-logistics at the site take place without the need of cardboard boxes/pallets and are performed virtually automatically via the application of barcodes. The products manufactured here include a variety of sealing plugs for tube/glass packagings that are used in the pharmaceutical or dietary supplement industry. Injection blown bottles for tablet packagings and nose/eye drops are also produced at the site in Peiting.

Extrusion and Co-Extrusion Production

The parent plant in Altenau is where the extrusion and co-extrusion production of airless-bottles, canisters for reagents, and special bellows with subsequent product refinement is performed. The Altenau plant also features two injection-moulding machines with state-of-the-art hygiene-equipment. These machines are currently used for producing the individual parts of a patented implant syringe that is then assembled right next-door in an ISO 8 cleanroom. An in-house special engineering department including SPS-programming, planning, assembly, and mould construction round off the portfolio at Altenau.

Quality and Customer Requirements

In order to ensure the best possible quality of their products, Gaplast pays particular attention to its quality management processes. The company not only fosters its employees’ creativity and willingness to learn, but also ensures that every individual understands that quality is a question of everyone’s attitude to her or his personal work. To ensure that its high quality demands are also met from a technological point of view, the company embarked on a search for a suitable CAQ software solution in 1998. Their market research led them to CAQ AG Factory Systems, as CAQ AG’s portfolio provided everything that is required for sophisticated quality management in the plastics industries. The portfolio also allowed the step-by-step expansion of the Quality Management Software by adding further modules at later points in time. The head of quality at the time was also convinced by the value-for-money and high return on investment of the solution. Cooperation between the companies Gaplast and CAQ AG commenced in 1998.

From Installation to Up-and-Running System

The implementation of the CAQ software solution began with the base module Compact.Net for inspection planning, quality inspection, SPC and LIMS, the complaint management module REM.Net, and the audit management module QAM.Net. Batch tracking and list characteristics as well as family inspection plans that the software offered were only a few of the aspects that were important to Gaplast. With the software solution, the company was now also able to automatically document and analyse quality-related costs as well as create individual forms via the form generator.

Soon after the inspection planning and inspection order processes had been redesigned to incorporate the software and the quality department employees had been trained in the use of the CAQ software, the system went live. The new increase in efficiency became evident at a very early point in time and meant that internal, customer, or supplier deviations could be seamlessly tracked and analysed with appropriate documents until they were resolved. Consistent standard-compliance could now also be ensured much more efficiently via the ready-to-use questionnaires in the audit management module.

More Efficiency for Initial Sample Reports

The employees were quickly convinced by the simple usability of the software and additional modules as well as additional licenses for existing modules were purchased. Due to the large number of material tests with differing material layer requirements in the co-extrusion area, Gaplast decided to purchase the EMP.Net module for initial sample testing in 2006. Ever since, this module provides invaluable support during the planning, execution, documentation, and management of standard-compliant initial sample reports. The application of this module once more showed the advantages of a CAQ solution with a centralized database over Excel-sheets and Word documents, as the structure of the inspection plan for serial production is already pre-planned in the initial sampling module and can then be directly applied in the production phase once it has been validated. The same works in the other direction as well, as a plan from the production environment can be reapplied to suit other variant sample inspections, saving Gaplast a lot of time in the process.

Multi-Language-Capable Across Locations

Gaplast has been using the multi-language-capability since 2006 in order to be able to provide its international customers with necessary documents in their own language. Once the characteristics are translated in the inspection planning phase, it is possible to e.g. issue inspection certificates in English, French, or Italian and provide them directly with the shipped goods. When the new production site opened in 2012, the necessity arose to restructure the database in order to be able to incorporate more than one site. Thanks to the SQL-Server Manager and terminal server, Gaplast can today work with one database from within both locations and only the data that is specifically relevant to the individual user or tenant is displayed. This further increases the user-friendliness of the system.

Training, Maintenance, and Risk Management

The training management module Qualify.Net was introduced in 2015 and now incorporates all information that is relevant to internal or external training measures. At the same time, all maintenance plans were revised and included in the PMS.Net maintenance management module. Ever since the 2015 revision of the ISO 9001 took place, the risk-based approach and a greater focus on risk management have become an even more important element of contemporary quality management. This means that companywide risks must be evaluated and considered in operational processes. Since its implementation, CAQ AG’s Risk.Net module is used as solution for said risk analysis and risk evaluation requirements. Several more CAQ modules are currently undergoing implementation at Gaplast that will, amongst other, consolidate, monitor, and control all tasks and actions of the individual quality assurance departments.

Quality Pays Off

Apart from assisting in the fulfilment of official quality standards – the resulting certification itself being of an unspecified monetary value – the application of innovative CAQ.Net solutions also brought with it an overall increase in process efficiency. The positive outcomes were communicated all the way up to top-level management. It subsequently ensured that being “quality-conscious” became a fundamental part of the company’s credo at all corporate levels. This helped form a reliable basis from which Gaplast could continue its strongly innovative approach in areas such as product research and development. This unique combination of innovation and quality assurance has brought Gaplast international recognition which not least lead to the company winning the prestigious DuPont Award for Packaging Innovation in 2008 and the German “Verpackungspreis” in the category functionality and convenience in 2016.