United States Pharmacopeia: Pharmaceutical Compound-Sterile Preparations Pt 5

Question 1

Gloved fingertip/thumb sampling inside the ISO Class 5 primary engineering control must also be performed at least every ____ months at the end of medial fill testing

Answer 1

6

Question 2

Measurements of air quality and presence of microbials in the primary engineering control (PEC) (ISO Class 5), within the segregated compounding area (SCA), must be certified by an approved outside organization at least every 6 months. This includes:

Answer 2

• Airflow testing
• High-efficiency particulate air (HEPA) filter integrity
• Total particle counts
• Smoke studies.

Question 3

Sampling of the interior of the primary engineering control (PEC) in a segregated compounding area (SCA) is required ____

Answer 3

monthly

Question 4

Sampling is performed by using a contact sampling device or plate with a growth media, such as ____ soy agar (TSA) with lectin and polysorbate 80. The plate is then inverted and placed in an incubator for 7 days at 20 °C to 25 °C followed by and additional 2 to 3 days at 30 °C to 35 °C

Answer 4

trypticase soy agar

Question 5

If the primary engineering control (PEC) sample exceeds the recommendations set by USP, a corrective action plan must be implemented. This may require additional cleaning, retraining of personnel, or verification of storage or ____ dates of the testing materials used

Answer 5

expiration dates