Charles River Endosafe Trillium rCR cartridges
 

Microbiology News: 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...

Improved R-CARD® Yeast and Mold Ideally Suited for Monitoring Mold Hazard in Premises

31 Jan 2023 | Food & BeverageOtherCosmetic/Personal Care

R-CARD Yeast and Mold Test Method
Save time by not having to prepare media or agar dishes. This test features a dye that will give a green or teal color to colonies of yeast and mold and an inhibitor to eliminate the growth of non-target organisms.   more...

INTERSCIENCE Range of New Products Improve Lab Workflow and Data Traceability

31 Jan 2023 | Food & BeverageClinicalLaboratory EquipmentCosmetic/Personal Care

Interscience new products
INTERSCIENCE's new products includes the instaBag range of blender bags that are supplied predosed, with ready to rehydrate media, the Scan 50 range of easy-to-use manual colony counters and the dataLink pro Petri dish labelling device for data traceability.  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...
Bioperfectus Total PCR Solution at Medlab Middle East February 2023
BioPerfectus is thrilled to be a Gold Sponsor and participate in Medlab Middle East 2023! We sincerely invite you to meet us to exchange ideas on Total PCR Solution that can improve operational and cost efficiency, optimize workflow, and increase performance at every opportunity. 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...
MICA Legionella provides equivalent or better results than ISO 11731 in 48 hours
Using its intelligent colony counter MICA Legionella, Diamidex solutions provide results for Legionella pneumophila (all serogroups) equivalent or better than the one obtained with the ISO 11731:2017 method. The MICA Legionella method has been compared to ISO 11731 by independent laboratories.   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...
Automated Nucleic Acid Purification
EZ2 Connect MDx can extract nucleic acids from blood plasma, serum, stool and other sample types using magnetic-bead technology. With a high degree of automation, the EZ2 Connect MDx enables labs to purify DNA and RNA from 24 samples in parallel in as little as 30 minutes more...
PTS 101D
For more than 50 years, BIPEA has provided a wide range of proficiency tests and external reference materials for testing laboratories concerned by quality control and analytical accuracy in various fields (environment, food, surface, cosmetics, pharmaceuticals). 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...
Full micro lab automation
From routine specimen inoculation processes to advanced incubation, imaging and colony selection for pathogen identification, the 3rd generation BD Kiestra™ Total Lab Automation System workflow can be fully automated and is customizable to fit the physical lab space. more...
 LuminUltra has partnered with the Greater Toronto Airports Authority (GTAA) to implement a cutting-edge, on-site laboratory to perform wastewater surveillance testing at Pearson International Airport. more...
Bio Rad iQ Check STEC VirX Kit
MicroVal approved Bio-Rad's iQ-Check STEC VirX Kit for the real-time PCR detection of virulence genes in Shiga toxin-producing Escherichia coli (#STEC) has been updated to include flour & raw dough (375g test portion) in addition to raw meat products (375g excluding poultry) and raw dairy products (25g). 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...
5 in 1 respiratory virus panel point of need test
Dragonfly is a portable testing platform that can differentiate 5 respiratory pathogens on one panel - SARS-CoV-2, Influenza A Virus (IAV), Influenza B Virus (IBV), Respiratory Syncytial Virus (RSV) and Human Rhinovirus (HRV) more...
VIDAS KUBE
The new VIDAS® KUBE™retains existing features of immunoassay automation of the VIDAS® but in addition meets the need of increased flexibility, traceability and ease-of-use. more...
Alertox Sticks
Hygiena’s new line of AlerTox® assays provide the high sensitivity performance food operators need to adhere to for more stringent product protocols that address the growing concern worldwide of serious, sometimes fatal, food allergies more...
HiMRSA Confirmation Agar Base M2126
HiMRSA™ Confirmation Agar Base is recommended for selective microbiological isolation of MRSA from other Methicillin-resistant Staphylococci species on the basis of coagulase activity from any clinical samples to further aid in actual infection diagnosis. more...