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News : pharmaceutical, Oct 2020

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Webinar: How the New EU GMP Annex 1 is Likely to Impact Your Aseptic Manufacturing

Webinar EU GMP Annex 1 and its impact on aseptic manufacturing
CleanroomEU GMP Annex 1Good Manufacturing Practice (GMP)
30 Oct 2020
Register for our webinar “Roadmap to compliance” and learn from our experts how to set up a risk-based environmental monitoring.

New Member of the Executive Board and Establishment of New Jobs

Norbert Schorpp of MBV and Fermon
Air Sampling
22 Oct 2020
MBV grows and expands its Executive Board by Norbert Schorpp. As a proven expert, Norbert will take over full responsibility for the internal value chain as Chief Operating Officer (COO).

New Rapid Response Environmental Surveillance Service is Launched in US

environmental monitoring mobile lab service
Cronobacter sakazakiiE. coliE. coli 0157
21 Oct 2020
Food manufacturers can now call on a rapid response on-site mobile lab to help pinpoint harborage sites and contamination issues within the facility. The lab can be on-site within hours, with the capability to process of more than 100 swabs an hour with results in 4 hours.  

Creative Diagnostics Launches SARS-CoV-2 Immunoassay Kits for Researchers

sars cov 2 immunoassay kits for research
AntibodiesELISASARS-CoV-2
19 Oct 2020
Creative Diagnostics introduces SARS-CoV-2 immunoassay kits for direct detection of SARS-CoV-2 antigens and antibodies. This kit is for Research Use Only (RUO).

One Stop Shop for Quick, Reliable Endotoxin and Beta-Glucan Testing

Image not available
Bacterial Endotoxin Test (BET)EndotoxinLimulus Amebocyte Lysate (LAL)
19 Oct 2020
The PYROSTAR® range, which provides 3 highly sensitive assays; Gel Clot Assay (GCA), Kinetic Turbidimetric Assay (KTA) and Kinetic Colorimetric Assay (KCA), for use with the ET-7000 toxinometer is now available in the UK from Alpha Laboratories Ltd.
 

How to Reduce Plastic Waste in a Microbiology Laboratory

making microbiology green
Greener Labs
16 Oct 2020
How replace and reuse practices in one lab resulted in 1670 tubes and 1300 loops being saved during a four-week period, a 43-kilogram reduction in waste. With £400 cost savings in plastic tubes, inoculation loops and cuvettes.

Short Talk: MAS-100 NT | Validation of the HEPA Filter

viable air samplers in high-grade cleanrooms
Air SamplingCleanroomMicrobial Air Sampler
15 Oct 2020
In this webinar, expert Dr Anne-Grit Klees covers the essential points of air sampling units for use in your high-grade cleanrooms, along with requirements for prevention of cross-contamination.

Short Webinar: Key Challenges When Selecting Media for Media Fill Tests

media fill tests or aseptic process simulations tutorial
BSE/TSEMedia Fill TestingMycoplasma
15 Oct 2020
This short tutorial guides you through the requirements for aseptic manufacturers when selecting media for media fill tests or aseptic process simulations. Also included are examples of products for aseptic process simulations.

Short Webinar: The New EN 17141 and its Implications for Culture-Based Active Air Sampling

EN 17141 and ISO 14698 standard for biocontamination control webinar
EN 17141 - Biocontamination controlISO 14698 - Biocontamination controlMicrobial Air Sampler
14 Oct 2020
This short webinar highlights the implications of the new standard EN 17141 for active air sampling as well as the selection and validation of culture-based active air sampling devices. Furthermore, there is a focus on efficiency tests and the effects from the new standard. 

Simplify Growth Promotion Testing with Microbiologics’ EZ-Accu Shot™

Microbiologics EZ Accu Shot is ideal for Growth Promotion Testing
Reference MaterialChallenge TestingGrowth Promotion Testing
13 Oct 2020
EZ-Accu Shot™ is the simplest way to meet USP/Ph. Eur./JP requirements for Growth Promotion Testing. Ready to use without dilutions, EZ-Accu Shot™ delivers 10-100 CFU per 0.1 ml for unmatched reliability and convenience.
 

What's on Show at PDA Global Conference on Pharmaceutical Microbiology 2020

Microbial QC Solutions from Charles River
Bacterial Endotoxin Test (BET)EndotoxinGrowth Promotion Testing
13 Oct 2020
Browse this rapidmicrobiology special focus bringing you the latest updates from the trade exhibition at the PDA Microbiology virtual conference. There's still time to register to attend this and the rapid microbiological methods workshop.

QC Lab Optimization Master Series Whitepaper Available for Download

down whitepaper QC lab optimization
AutomationBioburdenEnvironmental Monitoring
13 Oct 2020
In this whitepaper, author David Jones, Ph.D. explains how pharmaceutical manufacturers can create future-ready labs that use technology to overcome myriad challenges and why embracing innovation is imperative for organizations that want to remain competitive in the 21st century.

"Error-proofing" and "Future-proofing": Updating the BET

Automation of the BET method improves precision and accuracy
AutomationBacterial Endotoxin Test (BET)recombinant Factor C (rFC)
12 Oct 2020
Combining both recombinant Factor C and Robotics error-proofs and future-proofs BET assay execution in your laboratory, and helps comply with the “3 R” principles (replacement, reduction, refinement of animal use). 

MBV Introduces MAS-100 Regulus Digital Anemometer for Calibration of MAS-100 Microbial Air Samplers

Digital calibration MAS-100 air samplers
Air Sampler CalibrationAir SamplingMicrobial Air Sampler
08 Oct 2020
MBV AG has launched the MAS-100 Regulus® digital anemometer for compliant calibration and adjustment of the air flow of MAS-100 microbial air samplers.

ANSM Acknowledge NGS Firm for Quality Control of Biologics

ANSM authorize pharmaceutical establishment status to pathoquest
Microbial controlNext Generation Sequencing (NGS)Viral Safety Testing
05 Oct 2020
Pathoquest has obtained the administrative authorization of Pharmaceutical Establishment from the French Agence Nationale de Sécurité du Médicament (ANSM) for its biological drug testing activities by NGS and is the first company in French to do so. 

New Animal-Free Monocyte Activation Test for In Vitro Pyrogen Testing

Lonza animal free monocyte activation test MAT Pyrocell used for in vitro pyrogen testing
Bacterial Endotoxin Test (BET)EndotoxinPyrogen
05 Oct 2020
Lonza has released PyroCell™ MAT System, a new Monocyte Activation Test for in vitro pyrogen testing in US and European markets. The test does not use experimental animals and is comprised of Peripheral Blood Mononuclear Cells. 

Rapid Screening for Pluralibacter gergoviae Using the RiboFlow P/En® Test Kit

rapid screening for pluralibacter gergoviae with riboflow P En lateral flow test
E. coliLateral Flow AssaysPluralibacter gergovie
01 Oct 2020
SY-Lab has developed a new RiboFLow® test for the detection of Pluralibacter gergovie in cosmetics and personal care products. The RiboFlow® -P/EN enables the combined detection of this newly specified microbe, P. aeruginosa and E. coli. 

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