RESEARCH
SPONSORED CONTENT
Finally, every automated monitoring instrument should be built into an isolator or production line and should be able to communicate directly with the entire system to minimize errors.3
When equipment
has been selected, industry compliant IQ and OQ documentation - which will become part of the site’s quality system - must be finalized. Calibration should be completed concurrently with other equipment in the isolator and/or production line.3
Once in use, all service should
be completed on site to decrease the risk of production downtime or contamination.3
However, it is important to note that EM is an ever-
evolving process. As the industry’s understanding of growth cultures and biocontamination increases, along with the ability to detect microorganisms that may have been elusive in the past, monitoring systems and processes are improving.
Documenting, Controlling and Evolving Methodologies
Regulations regarding microbial testing are evolving to allow and encourage the adoption of advanced biological monitoring solutions.5
Add-ons to pharmacopeias now account for next-
generation therapies and offer alternative options, including rapid microbiological methods (RMMs), which are often used
for products with a short shelf-life or limited production size/ frequency.5
Additionally, the FDA amended its position on sterility test requirements with its final rule, effective June 2012.
According to the FDA, these changes are “intended to promote improvement and innovation in the development of sterility test methods by allowing manufacturers the flexibility needed for sterility testing of some novel products that may be introduced to the market.”6
EM is a safeguard although it remains imperfect. To illustrate,
monitoring systems often do not provide quality or quantity details regarding microorganisms and are typically unable to detect those that are viable but not culturable (VBNC).4
Further, according to a 2012
report from the World Health Organization, monitoring practices may be outdated for certain drug products: “EM GMP was written in an era when bacteria and fungi were the only microorganisms that could be readily identified, and septicaemia due to intravenously administered solutions was a major problem.”7
As technology and equipment continue to improve, aseptic processing capabilities are becoming increasingly advanced at controlling the risk of contamination, rather than just monitoring its presence. With these regulatory changes continuing to evolve, one lingering question remains: Is EM as useful or effective as it was thirty years ago?
Pharmaceutical Outsourcing | 42 | November/December 2016
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54