Product/Service

Capsule Filling System For High Potent Pharmaceuticals: GKF 720 HiProTect

Capsule Filling System for High Potent Pharmaceuticals

The GKF 720 HiProtect provides a high containment concept for the production of potent and costly niche products such as "orphan drugs” against rare diseases.

The HiProTect platform offers all features and functionalities from the GKF 720. It offers a washable containment concept (WIP) ensuring highest protection class for operators, up to OEB 5 product requirements (0.1 µg/m³). The GKF 720 HiProTect is able to produce small batches for research and development or clinical trial supplies.

Containment solution for high potent pharmaceuticals.

The GKF 720 HiProtect is equipped with inflatable door-sealings and provides a controlled and monitored negative pressure in the product handling area. Accesssibility can be ensured through glove ports and rapid transfer ports (RTP). Air inlet and air outlet HEPA filters are given.

HiProTect cleaning concept

Materials, design and cleaning appliances have been selected to achieve best in class cleaning results, in order to avoid cross-contamination from product to product and operator exposure.

The first step of the cleaning cycle is a manual dry suction of product residues via an integrated suction hose. The second step is the automatic wetting system based on an in-built spray nozzle. During the automated wetting process only 200 milliliters of water, in form of fine droplets, binds airborne particles. In the third step a manual wash-down of the processing area takes place, in order to remove last product residue. This can be repeated if necessary.

Benefits:

  • Washable high containment concept with reduced water requirement up to OEB5
  • Dust and water tight machine table through tabletop design and air-purge seals
  • Monitored negative pressure system
  • Exchangeable dosing modules for maximum flexibility
  • All filling systems support a feedback loop for automatic weight adjustment   
  • Improved door concept for maximum tightness, visibility and easy cleaning
  • PAT Classic with powder bed height control, transfer force determination and capsule closing force measurement
  • In-built gravimetrical scale with high accuracy load cell for consistent in-process control
  • Integrated net-weight detection system for 100 % in-line mass verification
  • Automatic troubleshooting function
  • No-cap-no-fill (no filling in absence of capsule body or cap)
  • Fast plug-in capsule carrier segments for fast capsule size change-over

Special feature: APD technology (automated process development) based on Design of Experiments (DoE)

Syntegon Pharma Technology Inc.