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News : pharmaceutical, 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

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.

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).

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.

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.

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