What are the key challenges to successfully implementing aseptic techniques and technologies?
Henderson: Some major key challenges with implementing appropriate aseptic techniques and current technologies are centred around clean
room design. Retrofitting a conventional clean room with isolator or RABS technology can be difficult because it will often
change the air dynamics and may require changes to the existing heating, ventilation and air conditioning (HVAC) systems.
Changes in HVAC are extremely expensive, which often deter companies from installing these types of technologies into existing
clean rooms. Another key challenge, is implementing technologies and practices that meet multiple regulatory expectations.
Companies who market and sell products globally must meet the compliance expectations of many regulatory authorities. Magriotis: Training of operators. Only highly skilled and disciplined operators can ensure the correct implementation of aseptic techniques.
Several companies can't (or don't want to) implement aseptic techniques because of inadequate company culture or the inability
to establish suitable standard operating procedures (SOPs). These factors sometimes represent real challenges for companies
Martin: The primary issue in implementing singleuse systems to replace cleanable stainless steel equipment (filter housings, piping,
tanks, filling lines) is the development of extractables data from the singleuse plastic equipment to validate that they do
not contribute chemical contaminants to the final product. The Bio-Process Systems Alliance (singleuse trade association)
has developed recommendations for single-use equipment suppliers to develop generic extractables data that can be referenced
by end users implementing the systems. Suppliers such as Pall have developed libraries of extractables data that can enable
users to conduct risk assessments without having to initiate new studies.
What future innovations do you predict in aseptic techniques and technologies during the next 5 years?
Changes to Annex 1 (manufacture of sterile medicinal products)
Henderson: In the next 5 years, I believe there will be additional consideration for reducing manual operator interaction during the
manufacturing process and making the process more automated. Manual aseptic operations provide a number of uncertainties and
risks. Currently, a popular topic for regulatory agencies is risk management of aseptic operations. I believe there will be
a large demand to make the process fully automated and thus reduce the associated risk. Magriotis: The use of sterile ready-to-fill vials (as it has already taken place with prefillable syringes). Also, I believe we will
see an increased use of plastic, such as cycloolefin copolymer, containers as an alternative to glass. Martin: Rapid microbiology methods will increasingly be employed for bioburden analysis and, in some cases, sterility testing. In
addition, automation (robotics) will minimize operator interventions to further reduce the incidence of false positives.
Pharma fails to comply: top tips from the MHRA
David Henderson Jr Manager, Sterile Filling, Ben Venue Laboratories, Inc.
Nicola Magriotis Macofar Product Line Manager, Romaco Group
Jerold Martin Senior Vice President, Scientific Affairs, Pall Life Sciences