Pharmaceutical Quality Control for Microbiology Resources

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Resources for Microbiological Quality Control

Our microbiological QC portfolio and guide for the Pharmaceutical Quality Control Microbiological Resources are designed to give you the best tools and information to meet the challenges you face day to day.

  • Fit-for-purpose 
  • Easy-to-use 
  • Efficient

As a QC lab technician, you play a crucial role in the pharmaceutical manufacturing process. We understand that safety and compliance are critical in your sampling, detection, and microbiological quantification processes. At Sartorius we offer smart solutions and microbiological QC resources no one else can offer. 


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Table of Contents

Chapter 1

Cellular Therapeutic Technologies: Rapid Detection of Bacterial Contamination

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Chapter 2

Cell-Based Therapies: How to Improve Patient Safety

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Chapter 3

Benchmark Microsart® Against Industry Leaders

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Chapter 4

Continuous Microbial Air Monitoring in Clean Room Environments

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Chapter 5

Reliable Septum Sampling In A Closed Loop System With Sterisart®

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Chapter 6

Microbiological Quality Control Throughout the Biopharma Production Process

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Chapter 7

Minimize the Risk of Mycoplasma Contamination in Your Cell Cultures

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Chapter 1

Cellular Therapeutic Technologies: Rapid Detection of Bacterial Contamination

Sterility testing is an important part of cell therapy production. At the moment, tests take about 14 days to rule out contamination - too long for cellular therapeutics with short shelf lives. Because of this, demand for growth-independent rapid assays has skyrocketed. Lab techs can’t afford to wait two weeks for accurate results. We need a better system. Microsart® can help. By coupling the Microsart® Bacteria Extraction’s DNA protocol with the Microsart® ATMP Bacteria’s real-time PCR assay, scientists may be able to get the results they need much more quickly, leading to faster drug production. It’s time to change your workflow. Here’s how.

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Chapter 2

Cell-Based Therapies: How to Improve Patient Safety

People shouldn’t have to worry about getting sick from microbial contamination. Our Advanced Therapy Medicinal Products (ATMPs) need better quality control. Current growth-based QC-release takes too long, causing labs to miss critical errors. Sartorius’s new workflow empowers lab technicians to obtain QC results within 3 hours and ensure non-contaminated ATMPs prior to treatment.
Here’s how Sartorius can help you improve patient safety. 
 

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Chapter 3

Benchmark Microsart® Against Industry Leaders

Traditional growth-based mycoplasma detection methods need at least 28 days to rule out contamination. With several different PCR kits to detect mycoplasma available, picking the perfect model for your lab can be difficult. To help you decide, we have benchmarked our Microsart® AMP Mycoplasma kit against two industry leaders to see which workflow achieves the best results. Learn more in our application note..

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Chapter 4

Continuous Microbial Air Monitoring in Clean Room Environments

Environmental monitoring is an important part of quality assurance for sterile pharmaceutical products. One small error can infect an entire batch, leading to wasted product or, worse, contaminated drugs on the market. EU GMP guidance calls for an air sample volume of no less than 1 m³ to be taken per sample location. But for an 8 hour work shift, this volume is too low to reliably judge air quality of the manufacturing environment. One way to improve product safety is by adding a continuous air monitoring system to your production process. In this study, we measured our gelatin membranes in pharmaceutical production environments. Here’s what Sartorius found.

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Chapter 5

Reliable Septum Sampling In A Closed Loop System With Sterisart®

In this study, the closed system sterility testing device, Sterisart® septum version, was evaluated for the recurrent sterile extraction of samples. The results demonstrate that even after more than 100 repeated septum sampling events, which far exceeds any foreseeable sampling requirements, the septum remains intact and the growth media contained in these canisters remains sterile. The Sterisart® septum allows easy inoculation and sampling, and enables the coupling of the conventional closed system sterility testing with rapid detection methods.
 

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Chapter 6

Microbiological Quality Control Throughout the Biopharma Production Process

From process development to final fill, there are a number of microbiological quality control measures to ensure drug safety. This infographic showcases Sartorius solutions for avoiding contamination at each stage of the biopharmaceutical manufacturing process.

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Chapter 7

Minimize the Risk of Mycoplasma Contamination in Your Cell Cultures

Preventing mycoplasma contamination in the cell culture lab can be a challenge. However, you can significantly reduce the risk of mycoplasma contamination and spread in your cell culture lab with good cell culture practices, by selecting easy-to-clean pipettes and sterility promoting consumables, and by regularly testing. Learn more in the application note from Sartorius.

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