The Pharmaceutical and Healthcare Sciences Society (PHSS) and the Pharmaceutical Quality Group are holding a joint conference to discuss EU GMP Annex 1 Draft. The MHRA have been invited to join in a discussion on the impact of Annex 1 revision in preperation for submission to the EMA.
The event will take place on 12th March 2018 at Woodland Grange, Leamington Spa. We will be attending if you would like to meet up.
For more information on the event please visit the PHSS https://phss.site-ym.com/events/EventDetails.aspx?id=1025801
Our managing Director Chris Maughan will be attending a ISPE decontamination and Validation workshop with ISPE on the 15th February. The 1/2 day work shop will focus on decontamination processes and rapid validation using Enzymatic Biological Indicators. For more information on this event ot to book please visit https://ispe.org/conferences/decontamination-and-validation
Installing thermocouples in a Steam in Place (SIP) system (Holding Tanks, Vessels, Fermenters etc.) can often lead to project delays. In order to reduce delays our engineers have a few simple tips which can help avoid any pressure test failures.
We have a produced a simple guide to installing thermocouples and biological Indicators which should help any SIP validation run smoothly. The guide includes selecting suitable thermocouples, smart clamps & gaskets and the application of suitable silicone. Our guide is free, just download the PDF below:
Porous load autoclaves usually control by either temperature or pressure. Assuming that all air has been removed from the autoclave chamber prior to the sterilisation phase the temperature and pressure should correlate. The theoretical temperature can be correlated by the pressure recorded by using steam table for example http://www.spiraxsarco.com/Resources/Pages/Steam-Tables/saturated-steam.aspx
Control of temperatures and pressures within the autoclave should fall within the control set points and correlate to steam tables. If excursions are identified then there are several potential route causes:
It is important to remember that high temperatures in an indication of dry heat, steam sterilisation is an effective method of sterilisation because of the moisture. Utilising dry heat as a sterilisation method requires much higher temperatures and extended hold times for example depyrogentation tunnels.
If you need any assistance with autoclave validation or steam quality testing please contact us.
Data loggers come in all shapes and sizes utilising different sensing technology from thermocouples to PT1000 sensors. The price and quality of these data loggers varies dramatically and the selection of sensor should be considered prior to perform a temperature mapping study.
We selected various calibrated data loggers with internal and external probes and placed them adjacent to each other in a -20°C Freezer. The graph below shows a snapshot of the results, comparing an external sensor logger to an internal sensor logger.
From the graph you can clearly see the temperature fluctuations of the freezer in the external sensor. The internal logger however does not record the same extreme temperatures. The air within the sensor acts as a buffer, effectively buffering the temperature fluctuations.
If you’re writing a risk assessment into the temperature mapping of your controlled temperature environments, consideration should be given to the sensors used to perform the mapping. Will the buffering effect of internal sensor impact the accuracy of your mapping exercise?
If you would like to read our full report on sensor selection and probe buffering please contact us.
Seasonal variations in weather can impact temperature and/or humidity control of warehouses. In order to ensure the stability of your warehouse it is recommended you perform summer and winter temperature maps.
In the UK and Ireland meteorological winter is between 01 December and 28 February. Meteorological summer is between 01 June and 31 August. So you should ensure your winter and summer maps fall between these periods.
We typically perform winter and summer maps over 7 days, this is to ensure the mapping includes changes in shift patterns, workflow etc. We can work to your own onsite protocols or generate bespoke protocols including the identification of sensor locations, risk assessments and validation requirements.
If you'd like to more please visit our temperature mapping services page or contact us for more information.
As both a NEPIC member and participant of NEPIC’s SME programmes, we were delighted to attend the recent Pharma Connect: India Special event, hosted by NEPIC (North East Process Industry Cluster) in Sunderland. NEPIC has forged strong relations over the last decade with the India Chemical Council (ICC) and the Karnataka Drugs & Pharmaceuticals Manufacturers Association (KDPMA) and their related member companies. This event brought together NEPIC member companies and the visiting Indian delegation to explore prospective synergies. We found it a fascinating opportunity to meet with Indian Pharmaceutical manufacturing representatives to discover opportunities they present.