N.42 – Suggested Frequency and Microbial Recovery rate of Sampling for Aseptic Processing Areas

TRIO

The USP 38 – The United States Pharmacopeial Document – Official from May 1, 2015 – presents on page 1197, Table 2 the “Suggested Frequency of Sampling for Aseptic Processing Areas”.

FREQUENCY OF SAMPLING

SAMPLING AREA LOCATION FREQUENCY OF SAMPLING
Clean Room / RABS
Critical Zones (ISO 5 or better)
Active Air Sampling Each operational shift
Surface Monitoring At the end of operation
Aseptic area adjacent critical zone
All sampling Each operating shift
Other nonadjacent aseptic area
All sampling Once a day
Isolators
Critical Zones (ISO 5 or better)
Active Air Sampling Once a day
Surface Monitoring At the end of the campaign
Nonaseptic areas surrounding the Isolator
All sampling Once per month

All operators are aseptically gowned in these environments  (with the exception of background environments for isolators).

These recommendations do not apply to production areas for nonsterile products or other classified environments in which fully aseptic gowns are not donned.

The USP 38 – The United States Pharmacopeial Document – Official from May 1, 2015 – presents on page 1199, Table 3 the “Suggested Initial Contamination Recovery Rates in Aseptic Environments”.

SUGGESTED INITIAL CONTAMINATION RECOVERY IN ASEPTIC ENVIRONMENTS

Room classification Active Air Sample
(%)
Settle Plate (9 cm) 4H Exposure (%) Contact Plate or Swab (%) Glove or Garment (%)
Isolator/Closed RABS
(ISO 5 or better)
<0.1 <0.1 <0.1 <0.1
ISO 5 <1 <1 <1 <1
ISO 6 <3 <3 <3 <3
ISO 7 <5 <5 <5 <5
ISO 8 <10 <10 <10 <10

All operators are aseptically gowned in these environments  (with the exception of background environments for isolators).

These recommendations do not apply to production areas for nonsterile products or other classified environments in which fully aseptic gowns are not donned.