Název projektu:
Novel freeze drying concept, with vacuum load-lock systems and robot technology for pharmaceutical/veterinary applications (11 NL 60FI 3LHY)
Popis:
A Dutch SME has developed a novel freeze-drying concept. By increaseing the active surface area, keeping the product in the same vial from beginning to end and a modular approach for each process step, several problems and bottlenecks of the traditional method can be avoided. Collaboration is sought for building a prototype using these design principles.
Freeze drying today is the most acceptable process for conserving pharmaceutical products. The process is extremely slow, making high investments in large plants necesary to achieve an acceptable throughput. Systems have already been developed for continuous freeze drying but these concentrate on bulk production, requiring an additional (highly inaccurate) powder filling step to get adequate doses. Apart from that, collecting powder from the bulk freeze dryer carries the risk of particle generation and other degradation effects.
The Freeze Drying process requires three fundamental steps:
1) controlled freezing
2) sublimation or primary drying
3) desorption or secundary drying.
In each of these steps the process conditions are different:
- during freezing pressure is atmospheric, shelves are kept at -50C;
- during sublimation pressure is ‹1 mbar, shelves are kept at 0C;
- during desorption pressure is ‹1 mbar, shelves are heated to +20C.
A heavy steel construction is needed for cleaning and sterilizing after each batch using superheated steam. Adaptation of the steel to each new process condition is time-consuming and essentially a waste of energy.
Two conceptual steps would make a continuous freeze drying process feasible:
- increaseing the active surface area
- modular approach for each process step.
With this modular approach appropriate process conditions for each module can be maintained eliminating delays and waste of energy.
Although many steps need to be taken to establish a functional prototype, the technology for each step exists in other industrial domains.
Freeze Drying and instrumentation is the key knowledge domain of the SME. To build a prototype for demonstration and investigation purposes requires collaboration with companies with a mechanical bias.
Technical Specifications / Specific technical requirements:
The usual constrictions in materials apply: no grease, stainless steel, some plastics are accepted.
Equipment must be sterilizable either by superheated steam or vapor hydrogen peroxide.
Reliability and traceability are of course standard requirements in pharmaceutical production.
A continuous process would offer many advantages.
- Processing the vials sequentially guarantees equal treatment for each sample, without the influence of local differences (e.g. position of the vial in the pack).
- Processing in a single line allows monitoring of the product in a non-intrusive way, providing better control of the process.
- A continuous process can be tailored to the amount of product that has been produced in the primary manufacturing process.
- A continuous process decreases the product risk (value and quality), because in the critical stage the quantity of end product is limited.
- A continuous process facilitates an efficient design of the cleanroom, resulting in savings on energy and operational cost.
Freeze drying today is the most acceptable process for conserving pharmaceutical products. The process is extremely slow, making high investments in large plants necesary to achieve an acceptable throughput. Systems have already been developed for continuous freeze drying but these concentrate on bulk production, requiring an additional (highly inaccurate) powder filling step to get adequate doses. Apart from that, collecting powder from the bulk freeze dryer carries the risk of particle generation and other degradation effects.
The Freeze Drying process requires three fundamental steps:
1) controlled freezing
2) sublimation or primary drying
3) desorption or secundary drying.
In each of these steps the process conditions are different:
- during freezing pressure is atmospheric, shelves are kept at -50C;
- during sublimation pressure is ‹1 mbar, shelves are kept at 0C;
- during desorption pressure is ‹1 mbar, shelves are heated to +20C.
A heavy steel construction is needed for cleaning and sterilizing after each batch using superheated steam. Adaptation of the steel to each new process condition is time-consuming and essentially a waste of energy.
Two conceptual steps would make a continuous freeze drying process feasible:
- increaseing the active surface area
- modular approach for each process step.
With this modular approach appropriate process conditions for each module can be maintained eliminating delays and waste of energy.
Although many steps need to be taken to establish a functional prototype, the technology for each step exists in other industrial domains.
Freeze Drying and instrumentation is the key knowledge domain of the SME. To build a prototype for demonstration and investigation purposes requires collaboration with companies with a mechanical bias.
Technical Specifications / Specific technical requirements:
The usual constrictions in materials apply: no grease, stainless steel, some plastics are accepted.
Equipment must be sterilizable either by superheated steam or vapor hydrogen peroxide.
Reliability and traceability are of course standard requirements in pharmaceutical production.
A continuous process would offer many advantages.
- Processing the vials sequentially guarantees equal treatment for each sample, without the influence of local differences (e.g. position of the vial in the pack).
- Processing in a single line allows monitoring of the product in a non-intrusive way, providing better control of the process.
- A continuous process can be tailored to the amount of product that has been produced in the primary manufacturing process.
- A continuous process decreases the product risk (value and quality), because in the critical stage the quantity of end product is limited.
- A continuous process facilitates an efficient design of the cleanroom, resulting in savings on energy and operational cost.
Požadavky na partnera:
Requested Cooperation: License Agreement, Assembly, Engineering, Quality control, Joint further development, Testing of new applications, Adaptation to specific needs, New way to use an existing production line
- Type of partner sought: Companies with experience in regulated environments are preferred. Knowledge of software and its qualification in regulated industries is an important asset. Equipment manufacturer in the pharmaceutical industry.
- Specific area of activity of the partner: expertise in mechatronics, validatable software systems, pharmaceutical experience.
- Task to be performed by the partner sought: Functional Specficication, Test Specification, Drawings, acquisition, assembly and integration.
- Type of partner sought: Companies with experience in regulated environments are preferred. Knowledge of software and its qualification in regulated industries is an important asset. Equipment manufacturer in the pharmaceutical industry.
- Specific area of activity of the partner: expertise in mechatronics, validatable software systems, pharmaceutical experience.
- Task to be performed by the partner sought: Functional Specficication, Test Specification, Drawings, acquisition, assembly and integration.
Obchodní firma/fyzická osoba:
Technologické inovační centrum s.r.o.
Sídlo/Místo podnikání:
Vavrečkova 5262
760 01 Zlín
760 01 Zlín
Kontaktní osoba:
Lenka Kostelníková
Email:
Telefon:
+420 739 570 792
