In this area of the homepage, the services are described which are performed for pharmaceutical companies and equipment manufacturers.

The services are designed to fill the interface pharmacy and engineering. Therefore validation and engineering are the major fields of activity.

• During validation the pharmaceutical requirement of the process will be checked (with original product). The aim of my consultancy and support is to successfully complete planning and testing of the existing pharmaceutical equipment during the Validation phase. The focus for this activities lies at the aseptic processes because this needs special attention due to criticality. The collaboration of Engineering (Automation, Design), Microbiology (Micro lab. and Quality Control) and Validation is therefore very important.
• In an early phase of development of the pharmaceutical equipment, Engineering can be supported by provisioning and representing the pharmaceutical requirements. It is necessary to develop technical solutions that fulfill this requirements.
• Additionally I am editing and creating Qualification and Validation documents. Technical Specifications and other technical Documents are as well within the scope of my activities.
• For vacancies in the Fill-Finish area, I can take on a temporary replacement either in the production or in the engineering department (Interim Management). After a new employee is available, there is the opportunity to do the training for the task.
• With the detailed knowledge of aseptic Filling processes, I can provide services for Deviation- and Change Management. These acivities are often documented with the TrackWise® software

Based on many years of experience with computer software validation, I can offer assistance on various topics in the field of automation.

The projects can be carried out worldwide. International projects are usually conducted in English language, this means the communication during the project will be in English. Documents will be created and edited in English.In German-speaking countries, the documents can be created and edited in German and the project language is as well German.

My services are based on aseptic filling systems for the production of liquid drugs. This includes:

• Filling machines for vials, syringes, pre-sterilized syringes, carpoules and ampoules.
• Isolators, above filling- and sealing machines.
• Transfer isolators and airlocks.
• Depyrogenization tunnels.
• Cleaning machines.
• Sealing machines for all the different containers.
• Upstream / Downstream Equipment e.g. Handling Units und Inspection machines.
• Compounding equipment.
• Freezedryers with automated loading- and unloading systems

• VHP Decontamination (vaporized hydrogen peroxide) with Isolators und Airlocks.
• In Process steam sterilization for containers and piping (SIP), Autoclaves.
• Depyrogenization processes by heat.
• Dry Heat Sterilization.
• Sterile Filtration processes for liquid products.
• Media fills
  
• Room classification tests.
• Freeze drying process with unit- and filter testing
• Saturated steam sterilzation of freeze dryers

• Reference D-Value determination for VHP Processes on Production Isolators by LHSKM (Limited Holcomb-Spearman-Karber Method).
• Support for microbiological and technical Investigations at OOS Results (Out Of Specification), especially for VP decontamination.
• Consulting for Inspection of Incoming goods for BIs used for testing during Validation activities.
• Optimization of manufacturing processes with Isolators, including loading schemes.
• Consultancy for Biological Indicators (BI) and Laboratory activities.

Bibliography:

Picture: anyaivanova / www.shutterstock.com