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29th March 2022  Content supplied by: rapidmicrobiology.com

Environmental Monitoring Solutions for Pharma Manufacturing - a rapidmicrobiology special focus


This rapidmicrobiology special focus showcases some products that are designed to help achieve an effective and compliant environmental monitoring programme within the pharmaceutical and biotech manufacturing sector.

Find suppliers of double and triple bagged contact and settle plates that are produced for passive or active sampling in cleanrooms, isolators and RABS, lockable lids help prevent accidental contamination. Gamma irradiated and performance tested, these products can have a long shelf life even at room temperature. Make sure the neutralizers required for your facility are included in the media to reduce chances of false negatives from residual biocides.

For active microbial air monitoring instruments, we highlight some high performance options available on the market, including one for continuous air monitoring as required by the new revision of EU GMP Annex 1. Plus you can now eliminate the need to validate sterilization of microbial air sampler heads by using sterile disposable microbial air sampler heads to ensure new Grade A zero biocontamination limits are met for EU GMP Annex 1.

After sampling comes the decision of how to get the fastest possible growth results, an automated plate reading platform will deliver real time results giving the earliest warning of out of specs whilst still using compendial based methods.

What to do with the isolates that are growing on your plates? Find out about how to compare and differentiate strains, whether to use 16s sequencing, Multilocus Sequence Typing (MLST) or Whole Genome Sequencing (WGS).

Then you can get your common environmental isolates or objectionable organisms prepared in precise dose formats, ready to use for quality control testing.

But don’t get swamped in data overload, be audit ready with demonstrable data integrity via software that has been designed to collect and collate environmental monitoring data, get track, trace and trend information at the push of a button.

Compliance Without Compromise for Your Environmental Monitoring

Compliance Without Compromise for Your Environmental Monitoring

Thermo Scientific™ Triple Wrap Plates are specifically engineered for environmental monitoring excellence in the pharmaceutical industry. The plates feature the latest in quality-assurance technology and are triple-wrapped and irradiated ready for use.
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EM-CULT ENLOCKTM: Ready Prepared Plates for Environmental Monitoring

EM-CULT ENLOCK<sup>TM</sup>: Ready Prepared Plates for Environmental Monitoring

Lockable ready prepared plates by HiMedia to avoid accidental opening of plates help you secure your environmental microbial monitoring results
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Got a Lot on Your Plate? Simplify your Environmental Monitoring.

Got a lot on your plate? Simplify your Environmental Monitoring.

Using your environmental isolate or targeted objectionable organism, we manufacture test-ready microbial controls quantitated for specific methods providing a complete solution to help you meet FDA, Pharmacopeia, and other regulations and guidelines.
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Keep Compliant and Audit Ready With New 3P® SMART PLATES

Keep Compliant and Audit Ready With New 3P<sup>®</sup> SMART PLATES

With GS1 barcodes and LOCKSURE® lids that decrease risk of manual errors and the new ultra-clear design that makes identifying and counting colonies easier through the lid, we can help you keep compliant and audit ready with the new 3P® SMART plates.
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Are You Confident in the Integrity of Your EM Data?

Are You Confident in the Integrity of Your EM Data?

Facilities using paper, spreadsheets and legacy Environmental Monitoring systems often lack confidence in their data. This is where SmartControl EM – software built in line with as GMP Annex 11 & CFR part 11 – can help.
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SAS Daily Heads Can Help Reduce Risk in Environmental Monitoring

SAS Daily Heads Can Help Reduce Risk in Environmental Monitoring

SAS Daily Heads are a viable way to help reduce risk and ensure compliance to the new stringent risk management and contamination control strategy within the revised EU GMP Annex 1. These certified sterile disposable air sampler heads provide an alternative to reduce the risk of false positives.
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Highest Precision in Microbial Air Sampling With MAS-100 Air Samplers

Highest Precision in Microbial Air Sampling With MAS-100 Air Samplers

For over 30 years, we develop and produce high-quality microbial air samplers. Many years of expertise and Swiss perfection have made us the world market leader. Our mobile and installed instruments offer you precision, sampling efficiency and reliability.
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Improve Your Facilities Monitoring Thanks to Condalab’s Culture Media

Improve Your Facilities Monitoring Thanks to Condalab’s Culture Media

Have you ever had to reject a batch due to microbiological contamination? Thanks to Condalab, you can efficiently monitor production plants, clean rooms and cleaning protocols, preventing potential contamination sources
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Digitalize Your Petri Dish and Accelerate Your EM with ScanStation

Digitalize Your Petri Dish and Accelerate Your EM with ScanStation

For the pharmaceutical industry, checking the air quality of sterile cleanrooms for the production of injectable sterile products is key to quality and productivity. More than 100 facilities are already equipped with ScanStation real-time incubator and colony counter for accelerated results.
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Continuous Viable Air Monitoring Solutions to Meet
EU GMP Annex 1

Continuous Viable Air Monitoring Solutions to Meet <br/>EU GMP Annex 1

The ImpactAir-ISO-90 and ImpactAir-90 ranges helps users address continuous monitoring challenges presented by the new Annex 1. The modular design provides differing formats to suit specific deployment needs and challenges within your facilities.
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Strain Comparison and Differentiation of Environmental Isolates in Manufacturing Environments

Strain Comparison and Differentiation of Environmental Isolates in Manufacturing Environments

Strain comparison and differentiation can be valuable in a range of circumstances. NCIMB’s Identification Services Manager, Vikki Warren, takes a look at recent developments in the methods available for doing this.
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Continuous Monitoring and Annex 1 - What is the Answer?

    

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Date Published: 29th March 2022


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