Single use technologies are an increasingly popular method of biopharmaceutical manufacturing. They differ from traditional biopharmaceutical process systems in that they are disposed of after use rather than cleaned of CIP’d (clean-in-place). However, the high cost, heavy reliance on vendors and storage limitations add to the doubt in whether they are worth the investment for both new and established manufacturers who are using stainless steel facilities.
This course will provide you with the answers to these challenges over the course of 4 weeks, where you will gain a comprehensive insight into the fundamentals of using single use technologies. Conduct an in-depth analysis of their key benefits and limitations to ease your decision on whether using them is the right choice for your institution.
Key Benefits of Attending
- Familiarise yourself with single use technologies, their different uses and Industry 4.0
- Gain a comprehensive insight into the facility requirements needed to integrate single use technologies into your manufacturing process
- Understand the key regulatory requirements applicable to single use technologies
- Critically analyse the benefits of single use technologies against stainless steel facilities
- Conduct a benefit – risk assessment to find out how single use technologies can be beneficial to your institution
Who Should Attend
This course is designed for those that are new to the use of single use technologies, such as:
- Development Scientists
- Process Engineers
- Manufacturing Managers
- Manufacturing Operators
- Quality Assurance Professionals
- 4 weeks
- 2 hours per week (average)
Click here: https://youtu.be/03tV6fxmyMs
Trefor Jones has a degree in Biotechnology and Biochemistry and is the Director of Bluehatch Consultancy Ltd. Trefor’s consultancy specialises in (cleaning) validation, technology transfer, process engineering and technical support. Trefor has previously served as the Head of Engineering at Cortex Pharmaceuticals and has 20+ years’ experience as a technical, production and project manager in the pharmaceutical and biopharmaceutical industries.
Why Attend An Online Academy?
Online Academy is an excellent forum to correspond with the teacher/instructor and your fellow students within the course while saving time, cost while maximising the effectiveness of bitesize chunks-learning and regular revisions
- Grow as a team – with multiple licenses your team can access the course and learn together, no matter where they are in the world
- Review all content as many times within enrolment period (two month after all modules have been released)
- Time effective – bitesize chunks so it does not impact on your normal working day
- Progress through the course with fellow students as you would in a classroom
- Discuss the course with fellow students
- Cost effective – no travel expenses
About BioProcess International Academy
BioProcess International Academy is a partnership between BioProcess International (BPI) and Pharmaceutical Training International (PTI). Our vision is to accelerate the growth of the biopharmaceutical sector by providing training solutions which are designed to enhance the technical skills, knowledge and competencies of biotech professionals. The Academy’s extensive course portfolio is determined by the latest industry trends and created by our global network of leading experts and delivered via workshops, digital academies and customised onsite programs.
BioProcess International Academy’s vision is to accelerate the growth of the biopharmaceutical sector by providing training solutions which are designed to enhance the technical skills, knowledge and competencies of biotech professionals. The Academy’s extensive course portfolio is determined by the latest industry trends and created by our global network of leading experts and delivered via workshops, digital academies and customised onsite programs.
Upon completion of your BioProcess International Academy online course you will be awarded with the CPD Certification certificate. This is a recognised independent CPD accreditation compatible with global CPD principles.
The Certificate of Achievement provides proof that you have taken the course and can be used on your CV or work portfolio.
Do sessions go out live?
No, all content is recorded and a set number of modules are released per week. You have unlimited access to module content once it has been released for the duration of the course and an additional two months.
Can I join after the course start date?
Yes, because modules are not live and all content is recorded you can catch up. Please contact us at email@example.com to enquire about joining a course after the start date.
Can I still take part if I’m away for part of the course run?
Yes. Online Academies provide a flexible learning format. As modules are not released live and are available for review, you will be able to catch up.
How long is my enrolment on the course?
You are enrolled on the course for the period that modules are being released and the trainer is active on the discussion forum (this varies from course to course – between 3 – 8 weeks) and for an additional 2 months after this to review course content.
Who do I contact if I have any problems while the course is running?
You should contact BPIfirstname.lastname@example.org
When will I receive my log-on details for the course?
Once you have paid, a member of the team will be in touch with your log-in details. We must receive payment for you to access the course.
How can I access the content?
Content is hosted on our Learning Management System, which you access using your device. A link will be provided to you with your log-in details.
What if I need extra time on the course?
Please contact us at email@example.com if you would like extra time on your course beyond the enrolment period. Extra time is subject to approvals and fees may apply.
What are Single Use Technologies?
- Short history of single use technologies (SUT)
- Growth of SUT
- Industry and commercial drivers
- Where are SUT used?
- Overview of SUT components
- Open vs. closed systems
- Pros and Cons:
- Heating and cooling issues
- Quality control
- Basic operation and controls:
- Filtering and types of filters
- Storage / freezing
- Overview of advantages and disadvantages
Stainless Steel vs. Single Use
- Hybrid systems
- Supply chain and issues
- Types of products (Components)
- Scale-up, scale down
- Role of SUT in process development
- Toxicity profile and leachables
Technology Transfer and Scale-up
- Unit operations
- Sensor technology & control software
- Validation & regulatory control
- Aseptic connectors / disconnectors
- Automation & standardisation
- The “Green” balance
Facility Requirements and Design
- Cost of new facility
- Personnel & material flows
- Warehouse requirements
- Water management
- Case studies
Standards, Guidelines and Regulations
- GMP requirements
- Testing, qualification, certification of suppliers and equipment
- What are the requirements for process control of SUT
- How to adapt the automation of new process requirements (ie in CMO or multi-product factory)
Benefit – Risk Analysis: should we use single use technologies?
- Supply chain
- Case studies
Looking towards the Future
- What’s needed for fully continuous production in SUT?
- Industry 4.0 and other future considerations
On-site & in-house training
Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?
Talk to us about an on-site/in-house & customised solution.