Examples of our recent work
Project 1: Containment / Handling highly potent substances
Location: Southern Germany (Rhineland-Palatinate)
Duration: 1 Year
Mandate: Projectmanager for the retrofitting of a GMP pilot plant or the processing of highly potent substances.
Planning:
• risk analysis
• timetable
• personnel locks with decontamination shower
• material locks
• production facilities / washroom / clean corridor
• waste-, waterwaste management and concept
• exhaust concept
Implementation:
• supplier selection, price negotiations and costing
• installation of the systems
• development of an emergency procedure in case of an unplanned product discharge
• elaboration of SOP for the use of the pilot plant
• elaboration of SOP for the cleaning of the pilot plant
• creating operating instructions (eg dressing instructions, the use of the decontamination shower)
• training of the general staff and the technical staff
Project 2: Containment / Handling highly potent substances
Location: Southern Germany (Rhineland-Palatinate)
Duration: 1 Year
Mandate: Projectmanager for the establishment of a weighing for highly potent substances. Project disposable weighing isolator. Category OEL 5 (<1μg/m3) and GMP requirements.
• creation of risk analysis
• development of a self-sufficient air concept with H14 filters to reach the vacuum in the isolators without burdening the existing ventilation system with highly potent dust
• development of the complete concept of the weighing of the highly potent substances within the isolator through the transfer to an intermediate container, to transfer into the mixing container
• supplier selection, price negotiations and costing
• installation of the system
• development of a cleaning concept
• development of cleaning, waste and sewage concepts
• development of an emergency procedure in case of an unplanned product discharge
• elaboration of SOP for the operation of the isolator
• elaboration of SOP for cleaning the isolator
• creating operating instructions
• training of the general staff and the technical staff
Project 3: Containment / Handling highly potent substances
Location: Southern Germany (Rhineland-Palatinate)
Duration: 2 years
Mandate: Projectmanager for containment and Subproject Leader for the full project of a weighing isolator. Establishment of a fixed isolator for weighing of highly potent substances with the company SKAN.
Planning and implementation of an isolator for weighing of highly potent substances within a production scale for the direct transfer into 120 liter mixing container.
Category OEL 5 (< 1µg/m3) and GMP requirements
• development of complete weighing procedure from the infeed of the material, to the transfer into the container
• development and selection of containment solutions for process
• development of a cleaning concept incl. Drying < 12 hours
• development of cleaning, waste and sewage concepts
• creation of risk analysis (hazards)
• supplier selection, price negotiations and costing
• creation of risk analysis (GMP), URS, FAT, SAT
• installation of the isolator
• development of an emergency procedure in case of an unplanned product discharge
• elaboration of SOP for the operation of weighing isolator
• elaboration of SOP for cleaning the weighing isolator
• creating operating instructions
• training of the general staff and the technical staff
Project 4: Containment / Handling highly potent substances
Location: Southern Germany (Bavaria)
Duration: 2 years
Mandate: Isolators for the production of development batches in the reference range of weighing, mixing and tableting. Including advice on the production space, material locks and personnel locks.
• development and selection of the optimal containment solutions for the process and isolators
• development of cleaning, waste and sewage concepts
• creation of risk analysis
• suggestions on supplier selection
• development of an emergency procedure in case of an unplanned product discharge from the isolators
• development of an emergency procedure in case of an unplanned product discharge from the isolators
• development SOP for the operation of the isolators
• development SOP for cleaning the isolators
• development SOP for the cleaning of the room, the material locks and personnel locks
• creating operating instructions (eg dressing instructions, the use of the decontamination shower)
• training of the general staff and the technical staff
