Webinars
Dec organizes and participates in many events throughout the year such as exhibitions, conferences and seminars. 2020 has seen the exception with the pandemic of COVID-19 where many events had to be canceled or postponed. So please benefit of the convenience to gain insight over the Internet directly on your computer.
The trend towards pre-filled disposable syringes whether of the single or dual chamber type is increasing. This webcast concentrates on the aseptic pharmaceutical packaging process challenges that need to be addressed in the final filling process of dual chamber syringes, where both liquid and powdery substances are mixed by the patient immediately prior to injection.
This practice shows clear advantages as it can eliminate preservatives needs while enabling longer shelf lives.
Filling syringes with liquid and powder in separate compartments is a big challenge in various respects. First of all not only sterility must be guaranteed throughout the whole process but also a very high degree of containment due to the high concentrations of the active ingredients contained in the powder. The required containment can only be achieved with complex isolators as opposed to open restricted access barrier systems (oRABS).
Another challenge is the requirement of a highly accurate dosing technology, able to precisely dose these active ingredients in the mg range which is, depending on the material properties, very difficult to achieve. There are also problems when the plungers are inserted into the syringes, because powder deposit on the inner surface of the syringe chamber can lead to leak issues which ca be prevented by pre-compacting the powder before its introduction.
This case study based presentation puts forward solutions to overcome these difficulties and shows best practices on how to integrate an aseptic syringe filling process in a single production line encompassing powder and liquid filling under controlled conditions.
How to effectively manipulate highly potent products in the pharmaceutical
and chemical industry
This live online event will give you the opportunity to gain insight on process innovation, occupational health and safety questions and appropriate technologies available today to overcome the many challenges in high containment manufacturing facilities.
The handling of HPAPIs is a highly complex process and calls for sophisticated equipment and process isolators.
Dec offers comprehensive solutions for R&D teams to production plants.
Topics include:
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Occupational Exposure Bands and Limits (OEB/OEL) and risk management
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Understanding all sources of contamination
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How to achieve OEB 7 levels
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Isolator contained transfer systems and powder transfer into the enclosure
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Process equipment interfaces
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Isolator environment and air filtration systems
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Cleaning - Hygenic design - Avoiding cross-contamination
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Isolator and glove integrity
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Case examples
Cómo unir la tecnología de transporte de polvos al concepto de aisladores para los procesos sólidos y líquidos
WEBINAR IN SPANISH
Recent years have shown steady growth in the manufacture of sterile and highly potent products in the pharmaceutical industry.
Antibiotics for intravenous or intramuscular injection in solid and liquid form for example should be produced under sterile conditions.
Due to increasing legislation and a better awareness of operator exposure risks, containment is a major concern for many industries. The latest regulations clearly indicate that risks must be addressed at their sources and that protection against exposure should be achieved by means other than personal protective equipment (PPE) and should be achieved to the extent possible by control measures through engineering.
The following questions will be treated
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Can different products be produced in the same plant?
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For high potency oral solid products, is the PTS Powder Transfer System applicable? How is cleaning validated?
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When using isolators in the microbiologic laboratories, what suggestions can be given in terms of design and specialization?
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Is it easy to validate the PTS Powder Transfer System along with the process?
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Is an isolator everything that has the name ISOLATOR?
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How to minimize static chrages and segregation during the powder transfer?
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What is the difference between RABs and an isolator?
The increase in toxicity and reactivity of pharmaceutical ingredients and the ever stricter production standards in terms of operator and environment protection as well as quality control have made containment essential and handling materials in non-closed environments is obsolete. The handling of potent or sterile products is usually the bottleneck in the design of a facility leading to complex and expensive processes.
The selection of technologies approved by the authorities is a key factor to the success of a pharmaceutical plant. As a recognized expert in high containment manufacturing equipment and process isolator technology, Dec offers comprehensive solutions for highly toxic, sterile and toxic-sterile materials which can overcome common hurdles. In this webinar we will show you our approach on designing modular manufacturing facilities allowing for quick product changes and generating high productivity.
Topics include
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Operator and plant Safety aspects
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High containment equipment for powder handling up to OEB 7
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Hygienic procedures (CIP/SIP)
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Linking processes; from batch towards semi-continuous manufacturing
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Sterile manufacturing
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Increasing productivity
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Latest trends in patient delivery systems associated to highly automated aseptic filling lines for liquids and powder