In February, AAMI released their updated aseptic processing guidelines. They have adopted the ISO/TC standards and are issuing this new series as a collection at a reduced cost. These ANSI/AAMI 13408 books will also be available for individual purchase. The first section of this new publication deals with the terminal sterilization of medical devices and other items. This final autoclave or low temp sterilizer step is performed on healthcare products in sealed containers prior to issuance by the manufacturer.

However, there are circumstances in which it is not possible to use this method due to packaging or other constraints. In such cases, aseptic processing can be considered as an alternate technique. AAMI’s documentation speaks to the precautions healthcare device manufacturers must take during this type of assembly. Preventing contamination of previously sterilized items as they go through the line can be difficult. Each component must be carefully handled to ensure that the final product remains aseptic. Section 13408-1:2008 provides valuable information on how to develop a comprehensive processing program.

Other sections of the 13408 publication cover clean-in-place and sterilization in place technologies. Lyophilization (freeze drying), filtration and isolator systems are also dealt with in depth. AAMI is anticipating that two new standards will be released by the ISO shortly. One of these new sections will be about the sterile production of items such as pacemakers and heart valves. The other will cover cell-based (isolated) manufacturing – a popular trend in aseptic processing. Approval of these new standards is expected as early as 2011.

2009 Training Opportunities

PDA Training and Research Institute (TRI) has just one aseptic processing course left in 2009 that has not sold out (session #4 in August-September). This class is broken up into 2 five-day sections to allow students to fully explore the presented topics. These intensive training sessions are scheduled a month apart to minimize organizational disruption for companies that choose to send their employees to TRI for training. This course is designed for technicians and supervisors as well as upper management in QC, Engineering, and Manufacturing departments.

The educational method consists of a combination of lectures and over 47 hours of team projects and hands-on training in a laboratory setting. Participants are expected to come away with practical knowledge that can be applied immediately to improve processes within their own organizations.

This course teaches such basics as facility design, airflow, sanitization, and other factors that affect aseptic processing. Knowledge of isolator technology, gowning, environmental monitoring, and other important functions will be tested as students perform media fills in TRI’s high-tech labs. Participants will learn how to sterilize and prepare components to reduce the risk of product contamination. They will also be taught proper documentation and final testing procedures to verify sterility.

Although aseptic processing can be a powerful tool, terminal sterilization is still the best option for achieving maximum microbe reduction. If you need to add a sterilizer or autoclave to enhance the quality control in your production process, read our free report to find out what type of equipment is best for your purposes.