New guidelines aimed at raising standards of contamination control in the pharmaceutical industry mean that organisations may need to re-assess their current practices, according to supplier firm Ecolab Contamination Control.
A number of the recent guidelines, such as the PI 007-6 PIC/S (Pharmaceutical Inspection Co-operation Scheme) ‘Recommendation on the Validation of Aseptic Processes’, the draft revision to Chapter 5 “Production” of the EU Guide to GMP and the MHRA’s Questions and Answers for Specials Manufacturers, all represent a shift in regulatory expectations.
PI 007-6 highlights the need to use sporicidal agents wherever possible, but particularly for ‘spraying in’ components and equipment to aseptic areas.
Ecolab says that this change means that users should consider a sporicide for transfer disinfection, rather than the alcohol which is traditionally used, but is not sporicidal.
Furthermore PI 007-6 PIC/S and the FDA Aseptic Processing Guide also state that the effectiveness of disinfectants and how they react on different surfaces should be validated.
However, the validation of disinfectant efficacy and time taken to achieve a satisfactory log reduction of the specific in-house organisms on the surfaces used in the manufacturing area places additional demand on internal resources, the group believes.
Another regulation with the potential to affect in-house processes is the draft revision to Chapter 5 “Production” of the EU Guide to GMP, which includes the requirement to avoid contamination for all products through the appropriate design and operation of manufacturing facilities, implementation of operational and technical measures commensurate with the risks assessed and controlled through the principles of Quality Risk Management.
James Tucker, Marketing Director at Ecolab said: ‘Our fully validated sterile product range for use in the cleanroom environment is manufactured in our own purpose built cleanroom, under conditions which match those of our customers, a fact highlighted by Process Match.
‘We also provide high levels of technical support, including product technical files, support for efficacy studies, as well as training and seminars.