APR January/February 2022 - 18

» MICROBIOLOGY
»
* Particulate and Foreign Matter
* Sterility
* Particle Size and Particle Size Distribution
* Antimicrobial Preservative
USP <5> Inhalation and Nasal Drug Products-General Information
and Product Quality Tests
Microbial Limits
The chapter states: The microbial quality of dosage forms where
indicated in <2> General Quality Tests for Inhalation Drug Products
and <3> General Quality Tests for Nasal Drug Products normally is
controlled by appropriate validated test(s) and acceptance criteria for
total aerobic count, total yeasts and molds count, and freedom from
designated indicator pathogens. Acceptance criteria can be expressed
on a per-container basis. Refer to Microbial Enumeration Tests <61>
Alternative Microbiological Sampling Methods for Non-sterile Inhaled
and Nasal Products <610>, and Microbiological Examination of Nonsterile
Products: Acceptance Criteria for Pharmaceutical Preparations and
Substances for Pharmaceutical Use <1111> for additional information.
The chapter should be revised to use the terminology as found in
<62> referencing specified microorganisms not designated indicator
pathogens. As aqueous nasal drug products may contain Burkholderia
cepacia that may overcome the antimicrobial preservative system, the
newer chapter Test for Burkholderia cepacia complex <60> should be
cited in <5>.
Sterility
The chapter states: " All aqueous-based inhalation dosage forms are
sterile preparations and should meet the requirements of Sterility
Tests <71>. "
Recommendations
The author believes that the risk factors emphasized in <1111> should
be extended to include the following:
* Non-sterile topical drugs used during invasive medical
interventions, e.g., central line catherization, surgery, mechanical
ventilation, wound dressing, etc. should contain a warning on
the labeling of the potential for microbial infection or be reclassified
as sterile products.
*
Immunological efficacy and biogenomic development that
varies with age and medical intervention.
* Emerging medical treatments, and organ and medical
device transplants.
* Microbial risk assessment going beyond genus and species
to strain, antibiotic resistance, and other genotypic and
phenotypic features
18 |
| January/February 2022
To <1111> Table 1 should be added the absence of B. cepacia complex
in 1 g or mL as a specified microorganism for aqueous preparations for
oral use, oromucosal use, cutaneous use, auricular use, and nasal use.
As USP chapter <1111> is a harmonized chapter, any changes would
need to be approved by the European and Japanese Pharmacopeias.
In the interim period, the revisions may be added to the chapter as
local requirements and brought up for review at future Pharmacopeial
Discussion Group meetings. Another strategy would be to add an
expanded discussion of microbial contamination risk and exclusion
of objectionable microorganisms to the USP general informational
chapter <1115> Bioburden Control of Non-sterile Drug Substances and
Products that is not harmonized.
References
1.
2.
Brook, I 2007 Infant botulism J. Perinatology (2007) 27, 175-180
Cundell, T. 2020a Chapter 2 - Microbial Contamination Risk Assessment in Non-sterile Drug
Product Manufacturing and Risk Mitigation in Pharmaceutical Microbiological Quality
Assurance and Control - A Practical Guide for Non-Sterile Manufacturing. D. Roesti and M.
Goverde (editors) J. Wiley & Sons
3.
Cundell, T. 2020b Chapter 11 - Exclusion of Objectionable Microorganisms from Non-sterile
Pharmaceutical Drug Products in Pharmaceutical Microbiological Quality Assurance and
Control - A Practical Guide for Non-Sterile Manufacturing. D. Roesti and M. Goverde
(editors) J. Wiley & Sons
4.
5.
6.
Fardet, L. I. Petersen and I. Nazareth 2016 Common Infections in Patients Prescribed
Systemic Glucocorticoids in Primary Care: A Population-based Cohort Study Plos Medicine
13(5): e1002024
Fishman, J.A. 2017 Infection in Organ Transplantation. Amer. J. Transplant. 17: 856-879
FDA Drug Safety Communication (2017): Clostridium difficile associated diarrhea can be
associated with stomach acid drugs known as proton pump inhibitors https://www.fda.
gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-clostridiumdifficile-associated-diarrhea-can-be-associated-stomach
7.
FDA
Letter to Health Care Providers - Stop Using All Eco-Med Ultrasound Gels and Lotions
Due to Risk of Bacterial Contamination Sept. 2021 https://www.fda.gov/medical-devices/
letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-duerisk-bacterial-contamination-letter-health
8.
9.
10.
11.
12.
George
M.D., J. F. Baker et al 2020 Risk for Serious Infection With Low-Dose Glucocorticoids
in Patients With Rheumatoid Arthritis A Cohort Study. Ann Intern Med. 173(11): 870-878
Houghteling, P.D. and A. W. Walker 2015 Why is initial bacterial colonization of the intestine
important to the infant's and child's health? J Pediatr Gastroenterol Nutr. 60(3): 294-307
Leistner L. 2000 Basic aspects of food preservation by hurdle technology. Int J Food
Microbiol. 55(1-3):181-186
Mullish, B.H., and H.R.T. Williams 2018 Clostridium difficile infection and antibioticassociated
diarrhea. Clin. Med. 18 (3): 2370241
Murphy, K. and C. Weaver (editors) 2017 Janeway's Immunobiology Figure 1.5 Garland
Science 9th edition
13. Olezkowicz, S. C., P. Chittick et al, 2012 Infections associated with Use of Ultrasound
Transmission Gel: Proposed Guidelines to Minimize Risk. Infect. Cont. & Hosp. Epidem.
33(12): 1235-1237
14.
15.
16.
17.
Rutala, W.A. and D.J. Weber, 2019 Guidelines for Disinfection and Sterilization in Healthcare
Facilities www.cdc.gov/infectioncontrol/guidelines/disinfection/
Simon, A.K., G.A. Hollander et al 2015 Evolution of the Immune System in Humans from
Infancy to Old Age. Proc. R. Soc. B. 282: 20143085
Singh, P. P., B. A. Demmitt, et al 2019 The Genetics of Aging: A Vertebrate Perspective. Cell
177(1): 200-220.
Yu, D, G. Banting and N.F. Neumann 2021 A review of the taxonomy, genetics, and biology
of the genus Escherichia and the type species Escherichia coli, Can. J. Microbiol. * 31 March
2021 * https://doi.org/10.1139/cjm-2020-0508
https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-clostridium-difficile-associated-diarrhea-can-be-associated-stomach https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health http://www.cdc.gov/infectioncontrol/guidelines/disinfection/ https://www.doi.org/10.1139/cjm-2020-0508

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