With his specialized and comprehensive knowledge about manufacturing and inspection procedures, in particular of sterile products, Dr. Haberers advice is a valuable help for our customers to draw the correct conclusions and find the best solutions for the individual microbiological problem. Dr. Haberer can give you advice in a broad microbiological field, as he has been challenged by many various projects in more than ten years of consultancy additional to the experience he gained in the pharmaceutical industry.
The consultancy services can functionally be differentiated in two fields. On the one hand, Dr. Haberer may help you with planning activities, e.g. with qualifications in establishing systems and equipment. This is the field of preventive measures prior to production.
The second field concerns with problems that develop in ongoing processes. Thus, Dr. Haberer is also able to help you with trouble-shooting in e.g. in case of contamination of a product.
Consulting in preventional measures:
- Qualification of systems, equipment and facilities for production of sterile products by terminal sterilization and/or aseptic processing
- Validation planning for production processes for sterile and microbiologically sensitive non-sterile products
- Development, optimization and validation of sterilization processes;
- Development and establishment of cleaning and disinfection programs for rooms, systems and equipment.
Consulting and trouble-shooting with microbiological problems
- Detection of microbiological contamination of product or environment
- Problems with complaints by regulatory authorities or other product claims
- Preparation of pending Inspections or audits
- Requirement of an expert report on the manufacturing process or the microbiological state of the product
- Demand of personnel training (in particular on hygiene and aseptic processing techniques)
- Hazard Analysis Critical Control Point
- Evaluation of rapid and alternative microbiological methods, comparability with classical compendial methods