News : Jan 2023

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Is Your Environmental Monitoring In Line With The New Annex 1?

How SherpaPharma supports Annex 1
21 CFR part 11Data Integrity
31 Jan 2023
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:  

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

R-CARD Yeast and Mold Test Method
Ready-to-use MediaYeasts and Moulds
31 Jan 2023
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.  

INTERSCIENCE Range of New Products Improve Lab Workflow and Data Traceability

Interscience new products
Colony CountersData IntegrityReady-to-use Media
31 Jan 2023
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. 

Annex 1: It's Here! - a rapidmicrobiology Special Focus

Annex
Special Focus Air SamplingEnvironmental Monitoring
30 Jan 2023
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.

Guidelines for the Manufacturing of Sterile Medicinal Products

EU GMP Annex 1 Guide
Environmental MonitoringEU GMP Annex 1
30 Jan 2023
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.

Microbiologics Custom Environmental Isolate Controls

Custom Environmental Isolate Controls
Microbial control
30 Jan 2023
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.

Microbial Monitoring Solutions for Sterile Medicinal Product Manufacturing Environments

Microbial Monitoring Solutions for Sterile Medicinal Product Manufacturing Environments
Air SamplingEnvironmental MonitoringReady-to-use Media
30 Jan 2023
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.

Stericheck® - Universal Operator Broth Transfer Validation Pack

SGL
Media Fill TestingReady-to-use MediaSterility Testing
30 Jan 2023
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.

Does Plate Choice Change Sampling Accuracy?

Does plate choice change sampling accuracy
Air Sampling
30 Jan 2023
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.

Red One™: Rapid Sterility Results in 4 days

Red One Rapid Sterility Testing System
Commercial SterilityEU GMP Annex 1
27 Jan 2023
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.

Cherwell Publishes New Guide to EM Best Practice in Compliance With Revised Annex 1

EM Processes and validation guide
Environmental Monitoring
27 Jan 2023
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.

PDA Announce New EU GMP Annex 1 Implementation Interest Group

PDA Annex 1 Implementation Interest Group
EU GMP Annex 1
25 Jan 2023
PDA's interest group and workshop will help the pharmaceutical/biopharmaceutical industry implement new requirements in Annex 1

Discover the BioPerfectus Total PCR Solution at Medlab Middle East

Bioperfectus Total PCR Solution at Medlab Middle East February 2023
Reverse Transcription PCR (RT-PCR)
24 Jan 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.

Designing an Effective Quality Control Process for Annex 1 Compliance

A QC Microbiologist at work
EU GMP Annex 1Sterility Testing
24 Jan 2023
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.

Can Legionella Water Testing Rapid Methods be "Better Than ISO 11731"? 

MICA Legionella provides equivalent or better results than ISO 11731 in 48 hours
AccreditationISO 11731 - LegionellaLab Water
23 Jan 2023
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.  

New Endotoxin Detection Reagent Developed by Recombinant Technology

PYROSTAR Neo
Endotoxin
23 Jan 2023
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).

EZ2 Connect MDx Platform for Standardized, Efficient Nucleic Acid Purification

Automated Nucleic Acid Purification
AutomationLaboratory Automation
23 Jan 2023
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

BIPEA Offers New Proficiency Test in the Field of Surface Microbiology

PTS 101D
Listeria spp.Listeria monocytogenes
19 Jan 2023
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).

NCIMB Now Supplies Custom Controls to Simplify Use of Your Environmental Isolates in QC Testing

A close up of a scientist in an NCIMB lab coat holding a Petri dish and picking off colonies
Environmental Monitoring
17 Jan 2023
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.

Environmental Monitoring: Microbial Air Samplers for Every Need

Microbial air sampler MAS-100 NT in cleanroom
Air SamplingAir Sampling IsolatorsMicrobial Air Sampler
17 Jan 2023
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.

BD Introduces Fully Automated Robotic Track System for Microbiology Labs

Full micro lab automation
AutomationLaboratory Automation
16 Jan 2023
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.

LuminUltra Participate in Innovative Wastewater Surveillance Pilot Project

Image not available
Mpox (monkeypox) VirusSARS in Wastewater
13 Jan 2023
 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.

MicroVal Approves Bio-Rad PCR Kit for Detection of STEC in Flour and Raw Dough

Bio Rad iQ Check STEC VirX Kit
E. coliE. coli inc VTEC/STECMicroVal
12 Jan 2023
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).

AnalytiChem Expands with bioTRADING Benelux B.V. Acquisition.

Image not available
Ready-to-use Media
10 Jan 2023
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.

AstraZeneca and LBT Partner to Develop APAS® Pharma for AI Based Microbial QC Automation

APAS Pharma Automated Microbial QC for Pharmaceuticals
AutomationColony CountersEnvironmental Monitoring
09 Jan 2023
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.

Dragonfly 5-in-1 Respiratory Test Panel Delivers Rapid Accurate Results at Point of Need

5 in 1 respiratory virus panel point of need test
InfluenzaRespiratory Syncytial Virus (RSV)Rhinovirus
09 Jan 2023
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)

VIDAS® KUBE™ - the Next-generation VIDAS® System Receives CE Marking

VIDAS KUBE
Laboratory Automation
05 Jan 2023
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.

Hygiena’s Allergen Detection Tests for Soy in Support of HACCP Protocols

Alertox Sticks
Allergens
04 Jan 2023
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

Identify and Confirm the MRSA Right in Your Plate

HiMRSA Confirmation Agar Base M2126
MRSA
03 Jan 2023
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.

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Puritan specimen collection devices are designed with people in mind
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Pyrostar Neo plus recombinant endotoxin detection reagent from FUJIFILM
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Bridging the Gap a rapidmicrobiology special focus
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