Risk Considerations for Aging Pharmaceutical Facility Cleanrooms

 

Pharmaceutical facility cleanrooms are designed to reduce and control particle contamination and to minimize the ingress and retention of microorganisms. Such risks typically are easy to control in well-designed, modern facilities. But risk mitigation is more difficult in older facilities.

 

 

Often, older facilities are maintained or even upgraded for commercial and compliance reasons. Plants that predate modern thinking (e.g., quality by design, QbD) might not be able to adapt to future opportunities or threats. Such facilities might be facing risks of microbial contaminations and thus require careful management during shutdown and start-up – hence the need for a risk-based approach.

 

The article examines the following risk considerations, which take on even greater importance as facilities age:

 

·         Is the facility suitable for the operations being carried out?

·         Is the facility readily cleanable?

·         Are there proper controls against cross-contamination?

·         Is there adequate ventilation to address sources of contamination?

·         Are there adequate sanitary facilities?

·         Are there separated operational areas to prevent mix-ups and cross-contamination?

·         What is the source of the water supply?

·         Are there adequate systems for the handling and disposal of waste?

·         Is there proper segregation between incoming and released components?

·         Are environmental factors such as temperature and humidity monitored and controlled properly?

·         Is there adequate storage space under the required environmental conditions?

·         Are in-process materials properly stored?

·         Is the facility equipment suitable for its intended use?

·         Is equipment designed to facilitate cleaning?

·         Are there proper filtration systems adequately and properly functioning?

·         Does equipment design prevent contamination from external sources?

 

To access the article, see: https://bioprocessintl.com/manufacturing/facility-design-engineering/risk-considerations-for-aging-pharmaceutical-facilities-and-cleanrooms/

 

The reference is:

 

Sandle, T. (2021) Risk Considerations for Aging Pharmaceutical Facility Cleanrooms, BioProcess International, 19 (5): 10 – 13

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

New approach could overcome fungal resistance to current treatments

 

Current medications aren't particularly effective against fungi. The situation is becoming more challenging because these organisms are developing resistance to antimicrobial treatments, just as bacteria are. Now, researchers report in ACS Infectious Diseases that they have identified compounds that tackle these infections in a new way -- by interfering with fungal enzymes required for fatty acid synthesis -- potentially opening the door to better therapies.


Superficial infections by Candida or other types of fungi can cause irritating but relatively minor conditions such as oral thrush and athlete's foot, but invasive infections can result in debilitating and deadly diseases such as cryptococcal meningitis and some hospital-acquired infections. More people are getting these infections because of the growing use of invasive surgery, implanted catheters and immunosuppressive therapy. And some patients, such as those with severe COVID-19 or HIV, are especially susceptible to fungal infections. In addition, treatments can be toxic and often don't work, in part because of increasing resistance. Current targets for these compounds include molecules necessary for making fungal cell walls. As an alternative, Glen. E. Palmer and colleagues began looking for potential therapies that could work through a different mechanism and thereby avoid the drawbacks of these drugs.

The researchers zeroed in on fungal fatty acid (FA) synthase and desaturase enzymes, which are essential for the growth and virulence of human fungal pathogens. It's been difficult to devise a rapid chemical assay to find inhibitors for these enzymes, since it's hard to isolate the enzymes. So the team instead combined genetic engineering with a whole-cell assay to screen thousands of small molecules. Although none of the tested compounds blocked FA synthase activity in Candida albicans cell cultures, 16 inhibited FA desaturase activity. A core acyl hydrazide structure was found to be key to the activity of several of these molecules, which were effective even against drug-resistant strains of several infectious species of fungi, while showing little to no toxicity to mammalian cells. The researchers note that these compounds are promising leads for further development as antifungal agents.

See:

Christian DeJarnette, Chris J. Meyer, Alexander R. Jenner, Arielle Butts, Tracy Peters, Martin N. Cheramie, Gregory A. Phelps, Nicole A. Vita, Victoria C. Loudon-Hossler, Richard E. Lee, Glen E. Palmer. Identification of Inhibitors of Fungal Fatty Acid Biosynthesis. ACS Infectious Diseases, 2021; DOI: 10.1021/acsinfecdis.1c00404

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Information Systems Impacting Building Supply Chains

Image: Pexels

It’s never good news when the words “Supply Chain” are included in a headline. Something along the line has gone wrong, and it likely affects several million people. Earlier this year the Suez canal debacle grabbed headlines when a container ship beached itself. The blockage exasperated a supply chain that was already under stress from Covid-19 and cost roughly $6.7 million per minute.

 Article by Indiana Lee

In the UK, Atul Kariya, a partner at MHA, recently commented that the labour shortages wreaking havoc on UK supply chains were “not caused by Brexit but has been worsened by restrictions on movement as a result of Brexit immigration rule changes, in addition to tax measures”.

 

The Suez Canal blockage and Mr. Kariya’s comments reflect an underlying theme: supply chain issues rarely exist in isolation. Instead, supply chain problems come in clusters. In the words of Jennifer Canstenon, writing for Forbes, “it’s a messy paradigm”.

 

Trying to establish a route through the mess of supply chain management is tricky at the best of times. However, recent developments in information systems show promising signs for the future. Widespread adoption of artificial intelligence (AI) is going to take time, but business leaders are already recognizing the potential risk-reducing benefits of AI-led supply chains. Construction is one industry that may benefit greatly from the wider adoption of AI in supply chain management, as it faces unique supply chain issues in our post-pandemic reality.

Supply Chain Issue in Building and Construction

Building and construction companies currently face a number of supply chain complications. This is a serious issue as poor supply chain management will lead to delays, fines, and inefficient business practices.

 

In the UK, Darren Dodd, of the Financial Times, has warned that warehouses across the UK may run out of space within the year. Further reports have found that 8 out of 10 builders are currently facing a materials shortage.

 

The stress placed on supply chains globally will invariably lead to higher costs, meaning that strategic leveraging of emerging information systems like AI will be pivotal for those looking to remain on track in construction and building.

Benefits of Information Systems

Complex information systems have been informing supply chain management decisions for a number of years. However, companies are now looking to leverage technological developments to boost supply chain resiliency and improve their bottom lines. By adopting new information systems like predictive analysis, companies can make more accurate forecasts of potential supply chain issues and can adapt their practices in response to increasing demands or potential areas of slack.

 

Information systems can also directly benefit the highly competitive building and construction industries. Knut Alicke, writing for McKinsey, found that “early adopters to [AI] improve logistics costs by 15 percent, inventory levels by 35 percent, and service levels by 65 percent, compared with slower-moving competitors”. For those in building and construction--who are often pitched directly against competitors--a reduction of logistical cost and an increase in inventory management efficiency of this level is impossible to ignore (particularly as the idea of self-building continues to grow in the UK and younger generations express significant interest in building their own homes).

Hires You Need to Make

In order to utilize information systems, companies need to hire information system specialists. Information system specialists are well-educated employees who combine various skills and approaches. They are adept computer system managers and are capable of maintaining and understanding key analytics, but they also have the ability to look beyond the program and consider the business as a whole.

 

An adept information system specialist should also be capable of managing teams, as supply chain management typically utilizes an array of employees who assert their value and specialisms along the supply chain.

Risks to Consider

The use of information systems in supply chain management is not a clearly defined science. It is impossible to predict the problems of tomorrow, and information systems must be redesigned to consider sustainability. In addition, AI relies on massive amounts of data in order to make accurate predictions.

 

Currently, there may not be enough data for AI to make accurate forecasts, and businesses that are transitioning to AI-led supply chain management may be feeling some growing pains. That said, the utilization of AI is all about patience. AI systems grow as data grows--as more data is made available, AI will have a greater tolerance and will contribute massively to the overall reduction of risk in supply chain management.

The Future of Building Supply Chains

Researchers and business leaders are always looking to align developments in information systems with current business practices. Advancements in artificial intelligence and the technology we use for shipping and handling can increase the overall efficiency of a supply chain, which ultimately improves companies’ bottom lines.

 

While there will be significant growing pains with all new technologies, the future of building and construction points towards technological development and the adoption of AI in decision making.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)