Environmental Monitoring (EM) is a crucial aspect of assessing the ongoing state of control in pharmaceutical and medical device cleanrooms. The appropriate use of disinfectants is also required to kill microorganisms that may trespass into the cleanroom and potentially contaminate the product or preparation. Despite the use of disinfectants, viable bacteria and fungi may occasionally be recovered from environmental monitoring, prompting an investigation.

During an EM investigation, a frequently asked question is whether disinfectants are effective against certain microorganisms, as some of these microorganisms are not listed on disinfectant labels or validation studies. Many also argue that a lack of disinfectant efficacy is rarely the root cause for recovering microbes during EM. Hence, it is important to understand how disinfectants and antibiotics kill microbes, the hierarchy of microbial susceptibility to disinfectants, and how disinfectants are regulated in different regions.

Over the last 5-10 years, remarkable advances have been made in endotoxin research. For example, irrefutable data have illuminated the biogenesis and structural differences of lipopolysaccharides concordant with Gram-negative microorganisms’ strain and the conditions they experience. Although the term autochthonous has not been well received in pharmaceutical microbiology, it is important to understand that endotoxins derived from autochthonous microorganisms in manufacturing environments are structurally different from those derived from laboratory-grown Gram-negative microorganisms. Moreover, this term provides an extremely useful microbiological adjective for originating in a particular place. As microbiology advances, we must also advance our language and definitions with fidelity to current art.

After several years of regulatory agencies expressing interest in better understanding disinfection practices in manufacturing facilities, an article called Current Practices in the Use of Disinfectants by Vivian F. Denny and Frederuc J. Marsik explains the evolution of cleaning and disinfection. It involved an eighty-question survey that was sent to 167 pharmaceutical companies to learn more about their disinfection practices. Many of those changes have affected cleaning and disinfection practices, and this article explores that evolution between 1997 and 2020 pertaining to:

Annex 1 Workshop Series will take place in Singapore and will feature international subject matter experts to guide the attendees through their Annex 1 compliance journey.

Over two days, the conference will cover:

Themed "Navigating through CMC Challenges", the 2023 PDA Advanced Therapy Medicinal Products Conference will be held in Baltimore, Maryland and will explore many facets of cell and gene therapies and present practical approaches to key issues currently facing the industry.

Topics to be covered include:

Themed "The Present & Future of Manufacturing & Quality of Cell-based Products", the program will cover sterility, process, and quality of cell-based pharmaceutical manufacturing. Learn more about the recent advancements in cell-based pharmaceutical manufacturing.

Take advantage of this chance to engage in discussions with the eminent thought leaders in the industry, government, and academe whom we have invited to speak at the conference.

Owing to concerns on cost, supply chain and profitability, the pharmaceutical manufacturing industry has begun to explore ways to innovate and incorporate technologies such as AI and automation into the manufacturing processes. The theme of the conference is "The Way Forward: Trends, Technologies & New Regulations Transforming Pharmaceutical Manufacturing”, and will focus on current and future trends as well as regulatory expectations.

Program Topics:

PDA and US FDA will once again co-sponsor this flagship conference which will be held in Washington, D.C, and will provide opportunities for attendees to learn about current issues relating to manufacturing and quality assurance. This year's theme is "CGMP: Quality Through Science and Innovation".

The conference will be held in South Korea and will focus on the manufacture of sterile drug products and patient-friendly applications. Take this opportunity to network with delegates and industry partners alike and gain insights which you can apply to your profession.

The conference will feature the most relevant topics on Aseptic Processing, including:

Ecovadis awarded Datwyler the Gold standard for our sustainability performance. Datwyler is among the top 5% of companies analyzed and in the elastomer industry ranks among the top 2% evaluated. This shows that Datwyler has made further progress and is fulfilling its social and environmental responsibilities with a clear sustainability strategy.

Streamlined Quality Control testing specific to cell and gene therapies yields safe, rapid, and efficient results.

Add rapid and easy-to-use technologies to your operations and bring overall efficiencies to the manufacturing process through both simplified workflows and accurate, actionable results to ensure patient safety.

Discover the bioMérieux’s proven portfolio through our technical notes and webinar series with customers.

Airex has completed the Smart EB®Hybrid, which combines the ultrasonic hydrogen peroxide decontamination method X'Sona® with a low-voltage electron beam. It is the world's first system that can continuously sterilize and decontaminate syringe tabs with a single EB.

Our sponsorship and partnership offerings help companies connect and engage with our PDA APAC members and network. Our events provide an excellent platform to reinforce your brand, showcase your products and technology, increase new business opportunities and demonstrate thought leadership and technical expertise.

If you would like to find out more about our partnership opportunities or on how to involve your business at our events, contact Cizlie Sunto (Ms) at sunto@pda.org.