14.0 Sampling Procedures Specific for Isolators—CACI & CAI

14.1  Viable sampling (air and surface) must occur in the main chamber, pass-through chamber and the environment that the isolator is located, even if the isolator is located in an uncontrolled area.
14.2  The sample equipment must be decontaminated before being placed in the pass-through chamber.

14.3  Move the sampling equipment into the main chamber following the manufacturer’s instructions for moving equipment into the chamber.

14.3.1  Be aware of the placement of equipment into the pass-through. Do NOT sample the surface in the area where equipment has been placed.
14.3.2  Be aware of placement of all sampling equipment in the main chamber. Do NOT perform surface sampling in an area where sampling equipment has been staged.

14.4  Set up the air sampler. Once the air sampler is ready to be started, the compounding personnel enter the isolator ports, don sterile gloves and perform competency testing or simulate compounding practices while the air sampler is running.

14.4.1  If the compounding personnel are performing their competency testing at the same time, the technician waits until the competency testing is completed before intervening again.
14.4.2  When the simulated/competency testing is completed, the compounding personnel will complete the gloved fingertip sampling on both hands before the technician intervenes. Do NOT disinfect the gloves prior to sampling. See section 23.3.6 through 23.3.9.

Best Practice: If the isolator has three glove ports and only two ports are routinely used, the unused glove port can be replaced with a port cover. However, all gloves that are present should be tested.

To read all of CAG-009 sampling procedure specifics for isolators, contact CETA International at 919-861-5576 or http://www.cetainternational.org/content/ceta-applications-guides.