Author Archives: P Yeatman

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.

Approaches to trend analysis of micro monitoring during aseptic processing?

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The Question posed on LinkedIn.

“Companies are expected to perform trending of their monitoring data. Detecting adverse trends should help to prevent exceedings of regulatory limits, as defined e.g. in Annex 1 to the EU or PIC/S GMP Guide for aseptic operations.

As you all know, microbial counts do not follow a normal Gaussian but a logarithmic distribution, such that the classical way of calculating and defining thresholds for alert (often +/- 2s) and action (+/- 3s) cannot be applied.

Hence, what alternative approaches to setting alert and action limits for microbio monitoring data (environment, staff, water, …) do you apply?”

My advice:

You need to have defined what your alert and action levels are and how many times in a row a site can be in alert before this constitutes an action. You also need to define how many below alert results may indicate an adverse trend.

Basically you want to get what is heading out of control under control.

You need to have a defined trending and reporting period and reports need to be signed off both by the microbiologist and QA manager.

Your internal process and documents will be dependant on which regulatory bodies have oversight at your facility.

The FDA, PDA, PIC(S), ICH and good resources like the PMF are valuable when developing your internal processes.

Some resources:
http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm124900.htm

http://www.microbiologyforum.org/content/file/PMFNews.17.03.1103.pdf

https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/midwest/making-sense-of-your-environmental-monitoring-data.pdf?sfvrsn=4

Patties Foods Frozen Berries

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I reply to a post on LinkedIn.

“The Patties Foods frozen berries scandal is a warning for directors about managing risks – what lessons could you learn? ”

My comment:

There’s lots of testing for bacterial contamination in such products as it’s regulated at Government level. Testing for viruses is not a routine requirement (it is not regulated). There’s been discussions on changing this as reportedly, about 20% of food contamination is caused by viruses and it might be a good idea to start testing.

No Current Experience – Catch 22 In Job Seeking

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Updated 20/06/2020

June 2020: Yet another “failed” job interview where I was passed over as “we went with someone with recent experience who can hit the ground running”.

Introduction

  • My last microbiology/science role was made redundant by my employer towards the end of 2012.
  • I’ve been trying to get back into a microbiology lab, QA department or related area ever since with zero success.
  • I stay active in science by reviewing regulatory updates and championing science via social media and by providing advice on LinkedIn, posting articles to share my experiences and producing online training presentations.

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