Modular cleanroom technology for pharmaceutical packaging systems - safe and flexible

HPT Pharma Packaging develops and manufactures, as a certified supplier, packaging systems for pharmaceuticals and diagnostics. Consistent investments in the latest cleanroom systems have led to high trust among demanding customers in the pharmaceutical industry and medical technology. The primary pharmaceutical packaging made of plastic, such as bottles, canisters, jars, and closures, are produced and packaged under controlled cleanroom conditions. The medium-sized, independent company has now increased its cleanroom capacity by an additional 250 sqm. The high acquisition and operating costs associated with complex cleanroom systems prompted consideration of a two-stage investment. Technical Director Alexander Stauch explains the approach: “We carried out the installation of the new cleanrooms in two separate construction phases. First, an independent cleanroom of 100 sqm was put into operation, and later the expansion was undertaken. This allowed us to distribute costs and increase our planning security.”

The cleanroom from the first phase is used for final inspection and repackaging of the pharmaceutical plastic bottles and closures. In an existing production hall, a self-supporting 100 sqm cleanroom system of GMP Class C, including personnel and material airlocks, was installed. The expansion of the cleanroom system by an additional 150 sqm for manual final assembly of closures was attached to the existing cleanroom.

A modular construction method that allows flexible expansion was therefore a requirement when awarding the contract for the new cleanroom system. In close collaboration with the cleanroom specialist SCHILLING ENGINEERING, planning for an expansion concept with GMP Class C cleanrooms was developed. The cleanroom system CleanSteriCell® meets these technically demanding requirements. It has a modular design and can be easily expanded or reconfigured even after commissioning. Thanks to a patented GMP Seal-Clip system, the wall panels are connected without silicone, so that the modules can be dismantled and reused without damage. The design of the climate control system and the installation of the innovative control system CRControl®, which can monitor and regulate all components of the cleanroom, were already considered for the overall size of the facility.

Shortly after commissioning the first part of the cleanroom, the planned investment in the expansion building could be made: “The installation and functional handling of the cleanroom system CleanSteriCell® went smoothly and fully met our expectations. The expansion of the cleanroom facilities to include an assembly room was then arranged relatively quickly. Our decision to opt for a flexible cleanroom system from SCHILLING ENGINEERING has definitely paid off,” emphasizes Alexander Stauch.

With the installation of the new GMP Class C cleanroom systems, the delivery of germ-free and high-quality packaging can be uncompromisingly guaranteed. ULPA high-performance filters and approximately 40 air changes per hour provide optimal controlled clean air conditions. For HPT, in addition to the high quality standards, responsibility towards employees and the environment also played a role in the investment decision. Spacious windows and the color scheme of the interior walls create pleasant workplaces. The installation of LED cleanroom lights and energy-efficient recirculation and exhaust air systems in the cleanroom walls help keep operating costs low and conserve resources.