If a device is marked sterile and
later found not to conform to its predetermined specifications
for sterility assurance, it is considered adulterated and may
trigger an expensive recall. Sterilization is, therefore, the
last critical manufacturing process prior to product release. In
spite of the critical nature of the process, most manufacturers
either cannot afford to hire an expert sterilization manager, or
cannot justify the expense due to the sporadic nature of
validation needs and the limited number of sterilization loads
that are processed each week. Many compromise by assigning
critical sterilization management duties to a staff member who,
while possessing the educational background, may lack the hands
on regulatory and operational experience. Many decisions, such as
process validation design, process development or modification,
and laboratory testing are often made with input from the very
vendors supplying the services. Urgent situations, such as
sterility failures, dose audit failures, process optimization,
product and/or process equivalency, bioburden spikes, load
configuration modifications, and packaging changes are not fully
evaluated before the solution is selected. While experienced
vendors strive to make recommendations that comply with current
standards, they cannot avoid protecting their own business
interests. The policy of many service and material vendors
dictates advocating de minimus compliance with current written
standards, i.e., minimum regulatory protection. For certain
device families, complying with the minimum regulations does not
automatically translate into the most scientifically sound
process. Everything a manager needs to know about sterilization
process validation and routine control cannot be learned by
reading six pages of standard requirements. For the serious
manufacturer we advocate regulatory compliance coupled with
good science learned through hands on experience for the
ultimately business protection.