Drawing from over 20 years of industry experience, gain valuable insights and expert perspectives from a trusted microbiology quality assurance leader and internal auditor.
The Question posed directly:
“Hi. I have a cleanroom question. When collecting an air sample with an air sampler device can you put the impactor head down when changing the plate. Can you put the lid of the plate down when you change the plate. What do you do with the two lids when changing the plate as I thought you could not put them down.
Thanks“
The following is an article I placed on LinkedIn and was written as part of my Developing My Writing While Helping Others series.
Paul Yeatman is a microbiologist with over 15 years’ experience in documentation, validation and running investigations in TGA and FDA regulated environments. He has a strong interest in process improvement, documentation, training and developing others. From 9-5 Paul investigates and solves software problems. By night he works on his science chops. He has an arty streak, runs several blogs and enjoys communicating his experiences and knowledge in arenas such as this. Continue reading
Microbiological trending of environmental monitoring data serves multiple purposes:
Here I summarise what each of my scientific roles have entailed.
As a Microbiology Officer, what does the day entail?
08:30 hrs – Start shift Continue reading
One of the main International Standards used as a reference document in a sterile pharmaceutical microbiology laboratory is ISO13408 – Aseptic Processing of Health Care Products . Long ago, I reviewed the 1998 edition. More recently, I acquired ISO 13208-1 (2008), so I compared my notes from the 1988 version with what is stated in the 2008 version. The use of italics is my way of emphasising points. Notes on changes are in blue.
INTRODUCTION
When I reviewed the 1998 edition, I did not note down any of the introduction.
I have experience developing training and presenting it to small to medium sized groups. Part of this process involves determining the way in which to present the training. Once such way to use some form of visuals in support of speaking. For my Microbiology for Non Microbiologists course, I used Microsoft Powerpoint.
Duration of Session:
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.
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
Trending, when used in a pharmaceutical microbiology laboratory, is the examination of long term data in order to examine if a controlled process is moving away from the state of control. Trending can also be used to determine the stability of a product’s efficacy by examining the results of testing over time. Stability trends are important to support expiry dates and storage conditions. Continue reading