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Microbiology News: pharmaceutical, Jan 2023


How SherpaPharma supports Annex 1
The 2022 version of the GMP Annex 1 defines some stringent requirements in relation to Environmental Monitoring. August 2023 is the deadline to comply. Are you ready? In summary, the following are the most critical aspects of the Annex related to Environmental Monitoring:   more...
Annex
The revised EU GMP Annex 1 is now over 50 pages and includes new requirements as well as additional detail on many of the existing requirements. Browse through our rapidmicrobiology special focus to see solutions on offer to help compliance. more...
EU GMP Annex 1 Guide
Manufacturing of sterile medicinal products is subject to special requirements in order to minimize risks of microbial, particulate and endotoxin or pyrogen contamination. Learn how to manage risks to medicinal quality and safety. more...
Custom Environmental Isolate Controls
Microbiologics simplifies environmental isolate and objectionable organism challenge testing by manufacturing your environmental isolates or target objectionable organisms into test-ready controls quantitated for your specific testing needs. more...
Microbial Monitoring Solutions for Sterile Medicinal Product Manufacturing Environments
With state of the art manufacturing facilities, HiMedia have an extensive portfolio of Microbiological culture media plates, microbial air samplers, and swabs, providing end-to-end solutions for monitoring of the environment. more...
SGL
The Universal Operator Broth Transfer Validation Pack is designed specifically as an easy to use all-in-one kit for process simulation to test aseptic operations in hospitals, pharmaceutical and other cleanroom environments. more...

Does Plate Choice Change Sampling Accuracy?

30 Jan 2023 | Pharmaceutical

Does plate choice change sampling accuracy
Read our report on our investigations into whether the choice of prepared media used within SAS air samplers can affect the sampling results achieved enough to impact whether your EM program is Annex 1 compliant. more...

Red One™: Rapid Sterility Results in 4 days

27 Jan 2023 | Pharmaceutical

Red One Rapid Sterility Testing System
Redberry offers the fastest Rapid Sterility Solution based on compendial sample preparation - incubation parameters and double canister device - in accordance with Ph. Eur. 2.6.1. This method is under validation and allows identification post-analysis. more...
EM Processes and validation guide
Download Cherwell's Environmental Monitoring eBook for a detailed review of all changes included in the extensive EU GMP Annex 1 59-page 2022 revision of key regulations governing the manufacture of sterile medicinal products in the UK and Europe. more...
PDA Annex 1 Implementation Interest Group
PDA's interest group and workshop will help the pharmaceutical/biopharmaceutical industry implement new requirements in Annex 1 more...
A QC Microbiologist at work
With the issuance of the revised version of EU GMP Annex 1, we’ve outlined the key elements and applicable solutions to help ensure your final product is protected from contamination and safe for patients. more...

Microbiology Product Launches Made Easy on rapidmicrobiology

23 Jan 2023 | Food & BeverageWaterClinicalLaboratory EquipmentPharmaceuticalMicrobiome

Need to introduce a new product to microbiology labs? Now it's easier than ever to get a rapidmicrobiology client account and book your promotional schedule on-line in jsut a few clicks. more...
PYROSTAR Neo
PYROSTAR Neo is a lyophilized reagent that combines 3 recombinant factors (factor C, factor B, proclotting enzyme) with sequences derived from Limulus polyphemus and a chromogenic substrate (peptidyl pNA). more...
A close up of a scientist in an NCIMB lab coat holding a Petri dish and picking off colonies
NCIMB is working with Microbiologics to offer custom environmental monitoring controls.  Using your own environmental isolate, identified at NCIMB, Microbiologics will manufacture test-ready controls, quantitated for specific Pharmacopeia methods. more...

Environmental Monitoring: Microbial Air Samplers for Every Need

17 Jan 2023 | Food & BeverageLaboratory EquipmentOtherPharmaceuticalCosmetic/Personal Care

Microbial air sampler MAS-100 NT in cleanroom
Sometimes it's the smallest things that matter the most. Minimal air contamination can have serious consequences. That's why MBV develops microbial air samplers that are high-precision, robust, fully validated and documented, as well as easy to use and clean. more...

AnalytiChem Expands with bioTRADING Benelux B.V. Acquisition.

10 Jan 2023 | Food & BeveragePharmaceuticalVeterinary

AnalytiChem Holding GmbH have announced the acquisition of bioTRADING Benelux B.V., a Dutch manufacturer of high-quality culture media in all forms of packaging. more...
APAS Pharma Automated Microbial QC for Pharmaceuticals
APAS® Pharma uses CCS’s cutting-edge imaging and artificial intelligence algorithms to automatically detect growth on settle plates, creating a digital record and plate image at the time of processing, automatically reporting negative results whilst providing increased traceability. more...


Fijifilm Pyrostar testing critical water used in the reprocessing of medical devices
 

SGL Plates and Culture Media for Pharmaceutical Microbiology
 

AI for microbiology
 

QC Standards Controls and Proficiency Testing Schemes
 

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