Author Archives: P Yeatman

Communicating With Customer Focus In Mind

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I have taken part in lots of training over the years.  Training is great as if it is new, one learns new things.  If the training has been done before, it consolidates or updates existing knowledge.  In July 2016, I took part in communication training.  Heading into the training, I was interested to see if my communication style had altered since the last time a DiSC assessment was used on me in 2009. As a trained trainer, I know all about communication styles and how to pitch training programs for effective knowledge transfer.  Day to day communication is similar and I enjoy observing how trainers train.

In 2009 I took part in training using the DiSC model run by a company called Bridgeworks.  From the discprofile website “DiSC is a personal assessment tool used to improve work productivity, teamwork and communication. DiSC is non-judgmental and helps people discuss their behavioral differences.”  Then I scored 5223, making me a “panther”.  That indicated I had a dominant personality and summed me up as:

  • Sees the big picture
  • Can be blunt
  • Accepts challenges
  • Gets straight to the point

Continue reading →

The Right Choice

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In January  2014, Company X advertised for a Lean Leader Microbiology role.  My application was successful and I attended both a first and second stage interview.

Though I reportedly excelled during the interviews and seemed to have a good rapport with the interviewers, I “did not have enough team lead experience” and the role went to “an internal applicant”.

This is a little frustrating.  I must not have conveyed my eight plus years experience leading teams of 3-15 scientists well enough.  Maybe having never had a difficult customer (at least in my opinion) was seen as a weakness. Continue reading →

Technical Illustration

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Shortly after beginning my very first microbiology role, I discovered a program called Microsoft Visio was installed on the work computers and it could be used to create diagrams.  I was performing  a lot of viable environmental monitoring duties at this time and the room maps were in need of improvement.    This was the perfect opportunity to improve some documentation. Continue reading →

Environmental monitoring: viable particles

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The Question posed on LinkedIn.

“Hi all, I would like to ask you about how to perform cleanroom microbiological environmental monitoring. Is it clearly defined in guides?
TSA and Sab at different temperatures or only TSA? If only one TSA plate, do you incubate at 20-25ºC and then at 30-35ºC, or only at one temperature?
Do you performe growth promotion test in same conditions?
Thank you for your comments!”

My advice:

USP <791> Environmental Monitoring Program Design and Application

USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments states “….time & incubation temps is made once…media have been selected. Typically…22.5 ± 2.5 and 32.5 ± 2.5…incubation time of 72 & 48 hrs, respectively. Sterilization processes used to prepare growth media for the environmental program should be validated &…media should be examined for sterility & for growth promotion as indicated under Sterility Tests 71. In addition, for the Growth Promotion test, representative microflora isolated from the controlled environment or ATCC strain preparations of these isolates may also be used to test media. Media must be able to support growth when inoculated with less than 100 colony-forming units (cfu) of the challenge organisms.”

So, pick your media. Test it. After that, validate your sampling recovery methods.

Air Shower Qualification

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The Question posed on LinkedIn.

“Can any body guide me how to perform the air shower qualification in potent drugs manufacturing? Is there any guidance for the same? Which test needs to be covered during qualification? ”

My advice:

Having worked in sterile production facilities, I’d consider an air shower a bad idea (increased particulates, impact on pressure differentials, ineffective removal of static particles (even creation of static particles) etc risk of forcing particles through PPE onto operator, cross contamination of surrounding de-gowning area/airlock).

I’ve found an old (2002) article that might help you with any URS and subsequent validation activities you develop:
https://www.alnmag.com/article/2002/12/how-do-air-showers-fit-contamination-reduction-plan

There are also two old (1999 and 2002) references at the end of the (linked) article.

Clean Room Grade for change room in Sterile Area

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The Question posed on LinkedIn.

“Please let me guide or give recommendations, what will be grade of change room just opening in Aseptic filling area. Please mention reference also.”

My advice:

PE 009-12 (Annexes) 2015.

Annex 1 states:
“Changing rooms should be designed as airlocks and used to provide physical separation of the different stages of changing and so minimise microbial and particulate contamination of protective clothing. They should be flushed effectively with filtered air. The final stage of the changing room should, in the at-rest state, be the same grade as the area into which it leads.”

So, what Grade is the filling facility? That is the grade you should validate your changing room/airlock to be.

A google search will find you the relevant PIC/S PDF.

Followup comment

You can download all the PIC/S documentation here: http://www.picscheme.org/publication.php

FDA Guide To Inspections

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A great reference for ensuring you are audit ready are the FDA’s Guide to Inspections documents and Guidance for Industry documents.

The FDA Inspection guides are freely available from here.

For my own reference and review, I’ve saved some of the Guidance for Industry documents below.  However, you can get them all from this link.

Did you find this informative or useful? Please consider a small donation so I can expand and improve on what I deliver.

Are Terminal Sterile Filters in Water Systems permissible?

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The Question posed on LinkedIn.

Post by a consulting company, “Are Terminal Sterile Filters in Water Systems permissible?”

My comment

Without reading the linked article, my gut feeling was no as viable monitoring would not be able to detect any contamination issues in the water lines. Additionally, a filter failure in a contaminated system could be a tad disastrous. I’d rather assure the quality of a system through monitoring, rather than a slap on filter.

Reading the article, I’d forgotten about endotoxin risk.

Disinfection of active air-samplers

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The Question posed on LinkedIn.

Avoiding cross-contamination when using microbiological air-samplers is a key activity. But how effective is the procedure? To evaluate this, Tim Sandle and Ravikrishna Satyada have written a paper based on test data…link to Disinfection of active-air samplers.

My comment:

For filling rooms, I’d always use a double wrapped autoclaved sampling head. For ancillary rooms where the risk to the product was lower, IPA was used rather than a new head.

With internal sanitation of air samplers, when I’ve validated units like the Merck MAS100 and Biomeriux RSC+, spraying with IPA was shown to be sufficient.

With regards of HEPA filtering the output airflow, smoke pencil studies showed laminar flow would take the air to the floor. Correct placement of the air samplers within the filling space and ensuring only samplers assigned to critical filling areas were used in critical filling areas would reduce the risk of cross contamination.

Good that you data showed effective sanitation and a lack (or low) cross contamination risk.