for highly potent substances,
the safety of human life and product is maximized."
Matthias Poslovski (Vice President Sales Turnkey), OPTIMA pharma GmbH
Smart solutions for highly potent drugs
Processing of highly potent substances: The whole picture decides
Optima Pharma developed a comprehensive and holistic process for the filling and processing of highly potent substances. The processing of highly potent pharmaceuticals requires special procedures to guarantee highest safety for human life and the product.
Many functions relate to each other and require a view of the entire picture. The individual consultation and design by Optima Pharma includes sophisticated room, pressure and waste water concepts since room and machine are only a totally functional system when they interact correctly. In addition, cleaning and decontamination are significant. Simulations of the cleaning process during the design phase support the correct layout.
Contamination plays a significant role. During the isolator design two different filter concepts are available – High Performance Filter and Bag-in bag-out Filters. An optimized machine design is also essential if highly potent substances are processed. This especially includes removable, and therefore, easy to clean, transport systems.
Key facts
Your benefits to process highly potent substances
An overall concept and implementation for:
- Pressure Concepts
- Waste Water Concepts
- OEL Calculation
- Machine Design
- Isolator Design
- Freeze Dryer Design
- Cleaning Concepts
Smart solutions
You profit from our solutions to process highly effective products
Machine design
You benefit through a coordinated machine design for highly effective products
- Optimized machine design of the line for processing of highly potent substances
- Special transport systems for optimized cleaning and to avoid carryover of contamination
- Comprehensive implementation of simulations for cleanliness and air flow
Isolator design
Your competent partner for isolator concepts to process highly effective products
High potent filter
- Easy accessibility to the filters
- Limitation of the highly potent area
- No wash-down of the return air ducts
Bag-in Bag-out system
- Easy realization of redundant filters
- Utilization of standard filters
- Easy accessibility to the manipulation unit stays intact
Cleaning concept
Your benefits through comprehensive simulations of the cleaning processes
- Optimization of the design for easy accessibility and cleaning capabilities
- Identification of worst case position and optimized water distribution
- Optimized positioning of the automatic cleaning nozzles for best cleaning results with minimum spray shadow
- Minimum water consumption and therefore, minimal contaminated waste water
- Operator free manual cleaning process
Freeze dryer design
Your benefits through a coordinated freeze dryer design for highly effective products
- Safe and gentle vial handling during loading and unloading to avoid possible contamination
- Safe discharge of exhaust fumes through appropriate filters in the suction hose of the vacuum system
- Cleaning and sterilization of the vacuum filter system to neutralize possible toxic substances
- Application of rinsable and de-contaminable vacuum pumps
