Training
Industrial training for Aseptic Practices
Who should attend?
- Individuals that are responsible for aseptic fulfillment,
- filling operators,
- QA/QC,
- Microbiology
- Trainers
- Facility/HVAC maintenance/
- Design, at all levels
Why should you attend?
With over 50 hours of hands-on lab time, this is the most complete and innovative aseptic processing training program available.
Course Description
This two-week Comprehensive training program, taught by industry-leading experts with over 15 years of combined experience. It will give you training and information needed to properly evaluate and improve your aseptic processes to reduce the risk of contamination.
Week One
- the fundamentals of aseptic processing, including facility design
- Velocity testing and airflow studies,
- Basic microbiology
- Cleaning and sanitization techniques
- Component prep & wrapping, training & regulations
- Environmental monitoring,
- Filtration and personnel qualification (including proper gowning techniques and aseptic technique evaluations).
Week Two
- Media fills validation
- Autoclave validation,
- Dry heat sterilization
- Product formulation
- Hold time studies
- Poss box validation ,
- Disinfectants validation .
- Microbiological identification
- Lyophilization
- Endotoxin
- Sterility and final product testing, sterilization and good documentation practices and root-cause analysis during investigations.
Our Faculty
Our faculty is composed of industry experts from around the world. We provide expert training by explaining the concepts, demonstrating the techniques in actual laboratory settings and verifying the understanding of those concepts. Some team members include:
Pharma Academy Name Executive Director and Founder Manoj has been a consultant to the pharmaceutical industry for over 14 years. Prior to that, he had 8 years experience in industry in roles of, Quality Assurance and Manufacturing, with companies including Mylan, Maneesh etc. He holds a Bachelor Degree in pharmacy.
Pharma Academy Name Executive Director and Founder Subhash has been consultant to the pharmaceutical industry for the over 15 years Prior to that, he had 8 years experience in industry in roles of, Regulatory compliance / Regulatory affair aseptic Manufacturing, with companies including Syncom formulation/ Alkem laboratories/ Ethypharma etc. He holds a Master Degree in Microbiology from BUU university. As a subject matter expert on Good Manufacturing Practices for component prep, maintaining sterility from the autoclave to the production area, and facilitating aseptic technique, he has been an instructor with the Aseptic Training.
Regulatory
- GMP Annex 1 - Manufacture of Sterile Medicinal Products
- FDA Home Page
- Freedom of Information (FOI)
- FDA Enforcement Reports
- Code of Federal Regulations (CFR)
- Federal Register
- The Ultimate FDA Phone Book
- Centers for Disease Control and Prevention
- Health Canada
Industry
- American Medical Association
- American Society for Microbiology (ASM)
- ASTM International
- Associations for the Advancement of Medical Instrumentation
- Biotechnology Industry Organization
- IHS Health Group
- Institute of Environmental Sciences and Technology
- International Society for Pharmaceutical Engineering (ISPE)
- National Registry of Certified Microbiologists (NRCM)
- Pharmaceutical Online
- Pharmaceutical Research & Manufacturers of America
FAQs
What is meant by aseptic?
Aseptic is the absence of microorganisms capable of causing infection or contamination.
What is aseptic processing?
A method of producing a sterile (absence of living organisms) product in which sterile bulk drug or sterile raw materials are compounded and assembled with sterile packaging components.
What is the objective of aseptic processing?
The objective of aseptic processing methods is to assemble previously sterilized product, containers and closures within specially designed and controlled environments intended to minimize the potential of microbiological or particulate contamination.
What is a clean room?
A room or suite of rooms where sterile conditions are required. The rooms have a defined environmental control of particulate and microbial contamination and are constructed, maintained, and used in such a way as to minimize the introduction, generation, and retention of contaminants.
What is meant by cGMP?
cGMP is the acronym for Current Good Manufacturing Practices. cGMP is defined as a set of current, scientifically sound methods, practices or principles that are implemented and documented during product development and production to ensure consistent manufacture of safe, pure and potent products.
Why must manufacturers establish environmental controls?
Manufacturers must establish and maintain procedures to adequately control environmental conditions where they could reasonably be expected to have an adverse effect on product quality. Lighting, ventilation, temperature, humidity, air pressure, filtration, airborne contamination, and static electricity are among many conditions to be considered for control.
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