A risk mitigation approach to detecting and quantifying metals in APIs

If trace quantities of metals are present in active pharmaceutical ingredients (APIs) or final drug products, they have the potential to adversely affect patients, depending on the dose, particularly if the metal is toxic, writes Scott Hugill, Analytical Department Manager for Sterling Pharma Solutions
DPS Group expands US HQ after major projects for Vibalogics and CRISPR Therapeutics

The EPCMV firm has expanded its headquarters in Massachusetts, just outside Boston, to expand its design and technical services personnel
Selection criteria for cleanroom garments with the new Annex 1

For the first time since 2008, the GMP Annex 1 guidance for the manufacturing of sterile medicine products has undergone a profound revision. The recently finalised document is more than a simple update, the actual guideline has been completely rewritten, as DuPont's Steve Marnach explains
NHS division chooses Technickon for new cleanroom projects

After Technickon solved a major humidity and AHU problem for the NHS Blood and Transplant division, the UK's national health service has engaged the company to oversee new cleanroom projects
End of an era: EU GMP Annex 1 has been finalised and published

After 14 years of many consultation periods, drafts, and revisions, the EU standard for "The Manufacture of Sterile Medicinal Products" has been completed and released to the public
Interview with BIM Manager Joe Murphy from Connect 2 Cleanrooms

As Building Information Modelling has become a more common practice, your BIM Manager has become more and more important. Joe Murphy talks about his career journey and some important lessons he has learnt in modelling a cleanroom project
LPS Industries’ flexible packaging cleanroom achieves ISO Class 8

Located in Moonachie, New Jersey, the recently completed cleanroom also passed its Safe Quality Food (SQF) Edition 9 Facility certification
Theragent pharmaceutical CDMO facility rakes in the build awards

The contract manufacturing facility for cell and gene therapies, with cleanrooms from AES Clean Technology, has been chosen as the winner for multiple national and state-level awards
Clean air specialist Crowthorne acquires Absolute Carbon Filters

The independent supplier of clean air and containment services in the UK and Ireland has added the new comapny to its Parts & Filters division
Micron pledges $100bn investment towards “Megafab” facility

New Green CHIPS Community Fund to invest $500 million in community and workforce development over time

Breaking News

Micron pledges $100bn investment towards “Megafab” facility

Micron pledges $100bn investment towards “Megafab” facility

New Green CHIPS Community Fund to invest $500 million in community and workforce development over time
Exyte acquires cleaning systems specialist Airgard

Exyte acquires cleaning systems specialist Airgard

Exyte CEO Büchele: “Acquisition will strengthen our position to support customers with technical solutions for their exhaust management.”
KLA announces plans for semiconductor R&D facility

KLA announces plans for semiconductor R&D facility

The new state-of-the-art innovation centre and manufacturing facility will include offices, cleanrooms, storage and support facilities and accommod...
BPR compliance: What does it mean for your hydrogen peroxide disinfection system?

BPR compliance: What does it mean for your hydrogen peroxide disinfection system?

The BPR is a two-step process that can be complicated to navigate, so this article by John Chewins gives a run down on how to do it, using Bioquell...
ABN is building the largest temporary hospital in Belgium

ABN is building the largest temporary hospital in Belgium

The mobile pharmacy enables UZ Gent to prepare their cytostatic and sterile preparations of medicines in cleanrooms in accordance with the strict G...
Device Technologies and MELAG complete decontamination room

Device Technologies and MELAG complete decontamination room

The three-year project came to a close at the Sunraysia Community Health Group Services Group in Australia
Selection criteria for cleanroom garments with the new Annex 1

Selection criteria for cleanroom garments with the new Annex 1

For the first time since 2008, the GMP Annex 1 guidance for the manufacturing of sterile medicine products has undergone a profound revision. The r...
A guide to choosing the best particle sample point location

A guide to choosing the best particle sample point location

Particle counting in pharmaceutical applications can be clearly segregated into one of three categories: certification, qualification and monitorin...
Tianjia completes new cleanroom purification workshop for Anhui Crystro

Tianjia completes new cleanroom purification workshop for Anhui Crystro

The move looks to help Anhui Crystro in its industry upgrade, who hope to continue to lead in the field of production and research and development
Medhini Group signs MOUs with multiple India-based cleanroom experts

Medhini Group signs MOUs with multiple India-based cleanroom experts

Malaysia-based Medhini has agreed to work with Modular Mobile Facility and DD Enterprises to bring their modular construction and CIP solutions to...
A risk mitigation approach to detecting and quantifying metals in APIs

A risk mitigation approach to detecting and quantifying metals in APIs

If trace quantities of metals are present in active pharmaceutical ingredients (APIs) or final drug products, they have the potential to adversely...
What is happening in the cleanroom market in 2022's DACH region

What is happening in the cleanroom market in 2022's DACH region

A look at the trends and major business deals through Germany, Austria, and Switzerland in a time of great turmoil across Europe
Theragent pharmaceutical CDMO facility rakes in the build awards

Theragent pharmaceutical CDMO facility rakes in the build awards

The contract manufacturing facility for cell and gene therapies, with cleanrooms from AES Clean Technology, has been chosen as the winner for multi...
Q&A: Halyard R&D Director talks cleanroom gloves for different sectors

Q&A: Halyard R&D Director talks cleanroom gloves for different sectors

Halyard Health's Siew Hoe Tan discusses the different considerations, requirements and advancements used when manufacturing gloves for semiconducto...
NHS division chooses Technickon for new cleanroom projects

NHS division chooses Technickon for new cleanroom projects

After Technickon solved a major humidity and AHU problem for the NHS Blood and Transplant division, the UK's national health service has engaged th...
Allergen management in food production

Allergen management in food production

Why choosing the right chemical and enzyme-based product for allergen management in the food, dairy, beverage and brewing industries is so important

In Brief

CREST making progress in fast-track manufacturing fit-out

Norwood completes compliant biotech cleanroom

Innovative expertise behind each door

ISPE Singapore

Efaflex innovative solutions

Thermo Fisher Scientific introduces safety cabinet series

ISCC’22

Conor Murray to co-chair and speak at Next Generation Pharmaceutical Cleanroom Conference

The value of Environmental Monitoring Systems through application programming interfaces

Cleanroom Conference Singapore 2022

Form v. Function: Why you shouldn't have to choose between style and performance

5 ways to mitigate risk in a cleanroom

New distributor announcement from PBSC

Pharmintech Exhibition & IPACK-IMA

Teknomek launches Hygienox tables designed for ultra-sterile environments

Austar Compliance Consulting Service wins antibody plant contract

ACHEMA 2022: Steriline's robotics and isolators as key features for the nest and bulk filling solutions

MedTech Innovation UK

Contec expands disinfectant line with new presaturated wipes

Cherwell announces support for the PHSS Annual Conference

Reverse osmosis in cleanrooms

CPhI Southeast Asia

AAF Europe and ClearSphere enter air filtration and equipment partnership in Ireland

UV Medico makes partnership in Hong Kong and Macao for far-UVC product

CREST finalise cleanroom reconfiguration works for leading CDMO

ICCCS

Most Popular

  1. A guide to choosing the best particle sample point location
  2. Selection criteria for cleanroom garments with the new Annex 1
  3. Micron pledges $100bn investment towards “Megafab” facility
  4. KLA announces plans for semiconductor R&D facility
  5. Exyte acquires cleaning systems specialist Airgard

Inspiration and Learning

FREE WEBINAR: Annex 1 and your Environmental Monitoring Plan
FREE WEBINAR: Annex 1 and your Environmental Monitoring Plan
Webinar on demand: Cleanroom routine environmental monitoring and classification
Webinar on demand: Cleanroom routine environmental monitoring and classification
Cleanroom Technology in conversation with EECO2
Cleanroom Technology in conversation with EECO2
Application note explains innovative technology that proves cleanroom suitability of CO2 incubators
Application note explains innovative technology that proves cleanroom suitability of CO2 incubators
Cleanroom Technology in conversation with AstraZeneca
Cleanroom Technology in conversation with AstraZeneca
9 key questions to ask about class 3 ISO cytotoxic isolators
9 key questions to ask about class 3 ISO cytotoxic isolators
FREE WEBINAR: The Danger of Poor Clean Room Investigations
FREE WEBINAR: The Danger of Poor Clean Room Investigations
Cleanroom insulation solutions go head-to-head in independent testing report
Cleanroom insulation solutions go head-to-head in independent testing report
Enhance your lab disinfection and decontamination protocols with SteraMist technology
Enhance your lab disinfection and decontamination protocols with SteraMist technology
Pharmacy Cleanroom Supply – for all your sterile and non-sterile cleanroom supplies
Pharmacy Cleanroom Supply – for all your sterile and non-sterile cleanroom supplies

Careers

ONFAB appoints new Director of Engineering
Leon Thornton joins Integrity Cleanroom as Sales Manager EMEA
NCIMB picks new CEO
Franz Ziel appoints new COO
Swedish design engineer KeyPlants announces new HR Manager
DPS Group promotes new Director of Aseptic Fill Finish
BES appoints youngest ever company director
Kemtile appoints HSEQ Manager to bolster health and safety
Piramal Pharma strengthens board by inducting three new board members
Vaisala appoints Anne Jalkala as Chief Strategy Officer

Reports

BPR compliance: What does it mean for your hydrogen peroxide disinfection system?
BPR compliance: What does it mean for your hydrogen peroxide disinfection system?
Selection criteria for cleanroom garments with the new Annex 1
Selection criteria for cleanroom garments with the new Annex 1
A risk mitigation approach to detecting and quantifying metals in APIs
A risk mitigation approach to detecting and quantifying metals in APIs
Q&A: Halyard R&D Director talks cleanroom gloves for different sectors
Q&A: Halyard R&D Director talks cleanroom gloves for different sectors
Allergen management in food production
Allergen management in food production
New standards for popular decontamination techniques
New standards for popular decontamination techniques
What are your pain points moving to Pharma 4.0?
What are your pain points moving to Pharma 4.0?
Meeting large-scale HPAPI production needs
Meeting large-scale HPAPI production needs
A fully custom cleanroom solution for a hi-tech company
A fully custom cleanroom solution for a hi-tech company
‘Plug and play’ autoclaves for a £4.2m research hub
‘Plug and play’ autoclaves for a £4.2m research hub