Thursday, 31 December 2020

Happy New (microbial) Year!


Happy New Year to all readers of Pharmaceutical Microbiology. Thank you foryour support and I'm looiking forward to delivering new topics and research for you during the coming year.

 Best,

Tim Sandle (Editor)

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

Wednesday, 30 December 2020

How Mobile HMI Workstations Enhance Cleanroom Practices


By Jason Maurer (Blue Line/Onlinestrategen.dk)

Cleanrooms, regardless of their ISO 14644-1 class, are characterized by the rigor and efficiency of their cleanliness routines and the reliability of their requisite technologies (e.g., airflow systems, pressure seals, computers). Mobile human–machine interface (HMI) workstations specifically designed for cleanroom use are a comparatively recent invention. Although trolly-mounted computers have been in use for more than a decade, they have typically relied on designs used in patient care facilities; as such, they were not designed to stand up to the rigorous cleaning practices characteristic of cleanrooms. In this post, I will explain the benefits of mobile HMI workstations in low-to-mid class cleanrooms (ISO 14644-1 classes B–D), particularly in terms of what they allow workers to do.

 

Designed For Continuous Operation

            As I explain in an earlier post, mobile cleanroom HMI workstations are designed from the bottom-up to ensure easy but rigorous cleaning, possessing good ingress protection (IP65+) and typically being resistant to even the harshest detergents. They are also designed for continuous use during an entire 8-hour shift: workers can switch them on and begin working as soon as they complete decontamination and donning personal protective equipment. Continuous (24/7) uptime is a necessity in production—even a brief shutdown in monitoring or equipment due to power outages or other electrical faults can lead to millions of dollars in lost batches and insurance payments. For that reason, mobile cleanroom workstations rely on hot-swap battery systems. That is, their batteries can be charged externally and then quickly inserted into the unit without loss of operation, thereby enabling workers to perform quick and simple handover between shifts.

 

Sensitive, Optically Bonded Touchscreens

            Touchscreens are in widespread use in our daily lives, but they are often despised by cleanroom workers because they tend to be insufficiently sensitive to use with multiple layers of gloves (a necessity for class B and C cleanrooms). Luckily, mobile cleanroom HMI touchscreens have been specifically calibrated for these higher-class cleanrooms, thereby ensuring that workers can utilize them without needing to remove gloves while also making sure that they do not react to non-user inputs (e.g., errant water drops during cleaning). This drastically eases cleaning routines and further limits the possibility of contamination. The highest quality touchscreens (see Figure 1) also feature auto-calibration, which helps to reduce translation, scaling, and rotation errors (1) https://www.embedded.com/how-to-calibrate-touch-screens/) and ensures a smoother user experience. Workers can thereby ensure that their work is completed with minimal interruption and frustration.

 



 

Figure 1. Auto-calibrated touchscreen

Moreover, cleanroom HMI touchscreens are built with optical bonding to ensure that they can be cleaned with liquids without worrying about the buildup of condensation over time, which can lead to fogging and the need to replace. Accordingly, cleaning agents can be left for longer periods to ensure decontamination.

 

One Size Fits All

            In smaller scale production cases—something that is becoming more common as companies branch out in personalized medicine or open up smaller facilities to improve local distribution—mobile cleanroom HMIs excel for their flexibility and utility. Workers do not have to contend with multiple HMIs, for one thing. They can move the workstation with them throughout the cleanroom, meaning that production can begin that much more quickly at the start and for far lower costs. This is especially useful in larger class D cleanrooms, where, even a few years ago, multiple HMIs might have needed to be installed. Workers can bond with a particular workstation that then travels with them as they complete their tasks throughout the cleanroom.

 

Conclusion

            Cleanrooms require technology suited to their need for efficiency and cleanliness. We expect that the use of mobile cleanroom workstations will increase in line with our knowledge of cleanroom science and best practices, given their tailored designs.

           

References

(1)   https://www.embedded.com/how-to-calibrate-touch-screens/

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Tuesday, 29 December 2020

Toothbrush contamination in communal bathrooms


 

Data confirms that there is transmission of fecal coliforms in communal bathrooms at a university, and that toothbrushes can serve as a vector for transmission of potentially pathogenic organisms.

 

All toothbrushes were collected from participants using communal bathrooms, with an average of 9.4 occupants per bathroom. Regardless of the storage method, at least 60% of the toothbrushes were contamination with fecal coliforms. There were no differences seen with the effectiveness of the decontamination methods between cold water, hot water or rinsing with mouthwash and 100% of toothbrushes regularly rinsed with mouthwash had growth on MacConkey agar indicating fecal contamination (n=2).

 

Fecal coliforms were seen on 54.85% of toothbrushes, which has been seen in previous studies. There is an 80% chance that the fecal coliforms seen on the toothbrushes came from another person using the same bathroom.

 

See: ASM


 

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

Monday, 28 December 2020

Can ‘Fuzzy Logic’ Be Applied To Risk Management In Pharmaceuticals And Healthcare?


 

Often in pharmaceuticals, especially when dealing with biological data (such as relating to product formulation or to microbial contamination), things are not always very clear and can appear vague. Another word for this is ‘fuzzy’. This is particularly so when trying to decipher whether a statement is true or false. In the financial sector, similar situations arise and one of the tools used to overcome this dilemma is to employ the thought process of fuzzy logic. Does this approach have a role in the pharmaceutical and healthcare products sector?

While some approaches to risk assessment, most notably Failure Modes and Effects Analysis (FMEA), us numerical scoring approaches, fuzzy logic is based on the fact that people generally make decisions based on imprecise and non-numerical information (even if they subsequently attempt to force their decision into a numerical value, as is required with FMEA). Fuzzy models provide a mathematical means to represent this vagueness and concerns about imprecise information (or what is said to be ‘fuzzy’).

For example, a temperature to kill a given microbial population will have separate membership functions defining particular temperature ranges needed to kill the population. Each function maps the same temperature value to a truth value in the 0 to 1 range. These truth values can then be used to determine temperature should be controlled. The fuzzy logic approach provides a means for representing the uncertaint.

Tim Sandle has written a new aticle:

Sandle, T. (2020): Can ‘Fuzzy Logic’ Be Applied To Risk Management In Pharmaceuticals And Healthcare?, IVT Network, at: https://www.ivtnetwork.com/article/can-%E2%80%98fuzzy-logic%E2%80%99-be-applied-risk-management-pharmaceuticals-and-healthcare

The advantage of fuzzy logic is that it provides valuable flexibility for reasoning by considering the uncertainties of the situation. Sometimes where there is too much certainty at the outset, this involves important data or events from being overlooked. With fuzzy logic, the outcome of an operation can be expressed as a probability rather than as a certainty. When the scope is too narrow and something important is inadvertently excluded, this can undermine root cause analysis and hence the assessment of all hazards that require assessing when undertaking a risk assessment.

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

Sunday, 27 December 2020

EDQM guidance on vaccines

 
The EDQM is committed to supporting competent authorities, manufacturers and developers of medicines, including vaccines, and health professionals during the COVID-19 pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and offering 

 

 free access to relevant standards and guidance.

Details of EDQM initiatives concerning COVID-19 vaccines and therapies can be found below.

·       Vaccine guidance, quality standards, OCABR guidelines and training

·       Antiviral medicines: supportive pharmacopoeial texts available for free

·       CEP fast-track procedure

·       Paediatric formulations

·       Illegal and falsified medical products and illegal online pharmacies

·       Advice to the public on illegal and falsified medical products

·       Blood transfusion and organ, tissue and cell transplantation

 

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

Saturday, 26 December 2020

Biosimilarity and Interchangeability


 

The U.S. FDA has issued a document titled ‘Additional Draft Q&As on Biosimilar Development and the BPCI Act’.  This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

 

The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.

 

See: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biosimilarity-and-interchangeability-additional-draft-qas-biosimilar-development-and-bpci-act

 

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

Special offers