Page 68 - Assurance of Sterility for Sensitive Combination Products and Materials

Aseptic processing 55

space. Manipulations and interventions associated with the monitoring in
the critical area should be minimized as well.
When environmental monitoring cannot be continuous or automated,
such as when the placement of plates or swabs in a critical area, the activity
is considered an intervention. Care and proper aseptic technique should be
taken to the place of materials or related environmental monitoring activ-
ities such as contact plates and swabs on product contact parts or surfaces.
When possible, it is preferable to execute tasks at the end of the aseptic
process or fill to avoid contaminating those parts or surfaces. Personnel
performing environmental monitoring may be quality, microbiology, or op-
erations personnel provided they are properly trained and supervised [7, 15].
Recovery rates for microorganisms/colonies can be variable, and this
fact should be considered when evaluating results. Monitoring that requires
personnel to intervene, such as swabs and contact plates, will increase vari-
ability. This variability and these recovery rates should be determined and
considered when analyzing and reporting results.
Excursions from prescribed limits or levels, as well as upward trends,
should be investigated. These excursions may not necessarily be the result
of system failure. The location, level, type of contamination, seasonal varia-
tion, activities occurring during the monitoring, and the impact on product
quality should be considered when deciding process and product disposi-
tion associated with from an excursion.

4.14 Personnel monitoring
Clean room operators, monitoring personnel, mechanics, and other clean
room personnel represent both a significant source and a risk of microbial
contamination. Personnel should be qualified to enter and perform their
functions in the clean room. Personnel qualification includes training, test-
ing, and ongoing monitoring.
Personnel monitoring should be performed at prescribed intervals
through the aseptic process. The monitoring may include finger impres-
sion plates for gloves, contact plates or swabs for gowns and other surfaces.
Personnel monitoring after gowning may be part of an overall gowning
qualification or continued verification of gowning technique.
Scheduled and random monitoring of gloves and gowns should be
employed, including personnel monitoring upon exit from clean room or
prior to re-gowning should be performed. Monitoring of gloves through
finger impression plating should be performed prior to removal of gloves,