Memo

CROZER-CHESTER MEDICAL CENTER PHARMACY

POLICY & PROCEDURE MANUAL POLICY NUMBER:

PAGE

1 OF 1

CATEGORY: IV ADMIXTURE PROGRAM REVISION #:1 EFFECTIVE DATE:

JULY 2005

TITLE: ENVIRONMENTAL MONITORING: AIR SAMPLING SUPERSEDES POLICY:

REFERENCES: ISSUED BY:

Jeffrey Baron

IV Supervisor

ADMIN. APPROVAL:

PURPOSE: Monitoring of work area environmental conditions, validation of aseptic technique, and sterility and pyrogen testing.

PROCEDURE:

1. Carefully remove EnviroTest paddles from their protective tubes just before using. Place one (1) EnviroTest in each work area of each Laminar Air Flow Workbench (LAFW) to be monitored. Position each EnviroTest at least 6 inches inside the work area. EnviroTests should be centered in work areas, with the agar surface perpendicular to the normal unimpeded air flow.

2. The exposure duration of the paddle to the air stream should be planned and the same each time the test is preformed. One hour is the time of exposure for all future tests. Exposure longer than 2 hours may dry the agar surface.

3. After inoculation or exposure, carefully replace the paddle in the vial and tightly

secure the cap.

4. Incubate at room temperature 20Ð'o-25Ð'o C for a minimum of 96 hours or at elevated temperature ( USP ) 30Ð'o-35Ð'o C for a minimum of 48 hours.

5. For proper interpretation of results, carefully remove from the vial and visually

examine under good lighting. Count the number of discrete colonies present, if any,

and report as colony forming units (cfus). Quantitative conclusions can be drawn

only when using the same sampling technique under similar conditions.

6. This procedure