Pharmaceutical Microbiology Basics
Details
Pharmaceutical Microbiology involves study of microorganisms associated with the manufacture of pharmaceuticals eg. minimizing the number of microorganisms in a process environment, excluding microorganisms and microbial by-products like endotoxin from water and other starting materials, and ensuring the finished pharmaceutical product is sterile. If the products are non-sterile, ensuring that the product bioburden limits are not exceeded. Pharmaceutical Microbiology covers managing and monitoring production environment, process, utilities such as water and compressed gases, and microbiological quality of product.
Who Will Benefit?
Quality Assurance, Quality Control, Microbiologists, Validation, Facilities, Materials and other health industry professionals and related vendors.
Outline
This one day intensive course will cover pharmaceutical microbiology procedures in:
Facilities- Qualification of clean and controlled environments
- Monitoring of clean and controlled environments
- How are environmental monitoring limits set and what procedures are used
- Importance of trending data and microbial identification
- Water system qualification and monitoring
- Compressed air and gas qualification and monitoring
- The importance of setting incoming microbiological quality of raw materials and excipients
- How product contamination risk can be mitigated with in-process testing
- In-process contamination issues-filtration and filter integrity testing
- Cleaning and sterilization of process equipment
- Compendial methods
- Non compendia tests
- Other microbiology related studies
- Importance of media in microbiological testing
- Good microbiology lab practices
- What are the different methods used or sterilization
- Sterilization validation
- Advances in automation used for pharmaceutical microbiology methods
Schedules
| No. of Days: | 1 |
| Total Hours: | 8 |
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AAPS is the Canadian premier Life Sciences and Pharmaceutical training college. The school was established in 2003 to address the growing demands by healthcare manufacturers for better prepared and more practically trained applicants. In tailored response, AAPS was designed and made operational by a team of highly experienced industry experts with one mission in mind; to create professional skill development programs that would exceed industry-training standards".
Employing only leading industry professionals with decades of experience, AAPS is setting the standard for pharmaceutical, food and healthcare training and career advancement. These experts continually develop and update the diploma programs and certificate courses at AAPS to meet the rigorous demands of the industry. ...
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