Download in electronic PDF format for $25



Search the Complete Journal Archives

Examination of the Order of Incubation for the Recovery of Bacteria and Fungi from Pharmaceutical-grade Cleanrooms

Author(s):  Sandle Tim

Issue:  May/Jun 2014 - Volume 18, Number 3
View All Articles in Issue

Abstract:  A study was undertaken to compare microbial recoveries from pharmaceutical grade cleanrooms using two different incubation regimes and a general-purpose agar (Tryptone Soy Agar). One temperature regime (A) incubated plates first at 30°C to 35°C, followed by 20°C to 25°C; the second temperature regime (B) began the incubation with plates at 20°C to 25°C, followed by 30°C to 35°C. The experimental outcomes demonstrated that there was no significant difference with the total microbial count when measured using a t-test (0.05 significance level; 95% confidence interval). However, with the recovery of fungi, the second incubation regime (B), which began with the lower 20°C to 25°C temperature, produced higher incidents and numbers of fungi. While this finding might provide the basis for adopting one incubation regime over another, a review of the types of cleanrooms recovering fungi suggests that fungal incidents are low, and they are more often confined to specific areas. Thus, as an alternative, incubation regimes could be varied to suit different cleanroom environments or a selective mycological agar adopted for specific areas.

Related Keywords: Tim Sandle, PhD, microbial recovery, pharmaceutical grade cleanroom, incubation regimes, agar media, Tryptone soy agar, formulation, bacterial contamination, fungi, fungal contamination, environmental monitoring, good manufacturing processes, culture conditions

Related Categories: ENVIRONMENTAL , FORMULATIONS, PEER-REVIEWED, QUALITY CONTROL

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Examination of the Order of Incubation for the Recovery of Bacteria and Fungi from Pharmaceutical-grade Cleanrooms Sandle Tim May/Jun 2014 242-247 Buy
Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: Science and Compliance Grilli Anthony, Sutton Scott Jan/Feb 2015 30-37 Buy
Five Compounds for Treating Diabetes-Related Conditions Meece Jerry May/Jun 2003 170 Buy
Healthful Living: Good Practices for Good Health Jackson Kathy May/Jun 2002 164-166 Buy
Basics of Sterile Compounding: Aseptic Processing Akers Michael J Jan/Feb 2015 49-56 Buy
Basics of Sterile Compounding: Contamination Control Akers Michael J May/Jun 2015 232-238 Buy
Microbial Identification in Pharmaceutical Compounding Hyde Tiffany, Anstead James, Schade Lisa, Zellner James Jan/Feb 2016 13-18 Buy
Pharmacy Cleanroom Project Management Considerations: An Experience-Based Perspective Kastango Eric S, DeMarco Sam May/Jun 2001 221 View Sample
Pharmaceutical Compounding or Pharmaceutical Manufacturing? A Regulatory Perspective Timko Robert J, Crooker Philip EM Mar/Apr 2014 101-111 Buy
Quality Control: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 2 Vu Nicole, Lou Jessica R, Kupiec Thomas C Jul/Aug 2014 305-310 Buy