Specialty Plants
Freeze Dryer
Incorporating a freeze dryer for the gentle dry freezing of high quality pharmaceutical products in the overall process is a challenge, which we address in close collaboration with the client from the initial design phase to the final process testing phase.
Along with the selection of the freeze dryer supplier best suited for the specific application, qualitative and quantitative specification of the necessary media such as pure steam, pure water, process air, cleaning media (CIP design), electricity, steam, cold water, instrument air, and connection to the waste water system, is the basis for successful implementation of a freeze drying system.
The preparation of the technical specifications of the equipment used, the illustration of the process flow by means of pipework and instrumentation flow charts, the preparation of a 3D model and the pipework isometrics resulting therefrom, the description of the automation, the installation of the facility and its accessories, the compilation of the necessary documents and protocols and the carrying out of the quality-relevant procedures based thereon, such as the Factory Acceptance Test, Site Acceptance Test, Installation Qualification, Operation Qualification, up to and including the final process qualification testing add up to a self-contained management package with complete, GMP compliant documentation.
Cleaning Systems
The cleaning of containers, tanks, hoppers, funnels, sampling systems, lines, miscellaneous small metal and plastic parts, and glassware is necessary to ensure a uniform flow of materials within the process zone.
The selection of a suitable cleaning system according to its function in the process, the incorporation of this system in the plant layout, taking into account the personnel and material flow and the specifications for the required media (pure steam, pure water, cleaning chemicals, process air, electricity, heating steam, cold water, instrument air, and connection to the waste water system) in terms of quality and quantity are questions that need to be resolved at the start of a project. The latter are clarified and defined jointly with the client during the preliminary design phase.
After the technical specifications, including user-relevant requirements, are compiled, a suitable subcontractor for the cleaning system is determined in the scope of an evaluation procedure.
During the carrying out of the project, compliance with client requirements is ensured by supervision of the manufacturing, carrying out a Factory Acceptance Test, supervision of the installation and integration in the process zone, and supervision of start-up, including a Site Acceptance Test. Appropriate documentation based on the instructions and protocols developed during the engineering phase is compiled.
The GMP compliant documentation of the carrying out of the installation, operation, and process qualification jointly with the client concludes the implementation phase for a cleaning system.
Sterilizers
Along with a well-planned personnel flow, a uniform material flow, including product flow, is of key importance in the designing of a pharmaceutical plant. Specifications for the use of sterilizers for ensuring orderly materials management to the process zone, from the process zone, and within the process zone are established jointly with the client during the design phase.
The selection of a suitable sterilizer according to its function in the material flow (production autoclave, decontamination autoclave), the effects on the plant layout, and the required media (pure steam, pure water, process air, electricity, heating steam, cold water, instrument air, and connection to the waste water system, as well as the matter of energy recycling) are key topics that must be dealt with at the start of a project for a successful implementation.
After the technical specifications, including client-relevant requirements, have been compiled, a suitable subcontractor for the sterilizer is determined in the scope of an evaluation procedure. An implementation suited to the superordinate material flow, wherein complete documentation is a given, is ensured through methodical control of the manufacturing processes, including a final Factory Acceptance Test, supervision of the installation in the plant and start-up with a final Site Acceptance Test, and carrying out the testing of the installation and the process jointly with the client.
