Performance Equivalence and Validation of a Rapid Microbiological Method for Detection and Quantification of Yeast and Mold in an Antacid Oral Suspension

Harold A. Prada-Ramírez; Ángela Aurora BeltrÁn-Osuna; Sandra Celeita; Juan Camilo Fonseca

doi:10.5731/pdajpst.2021.012632

References

1.↵
1. Saghee M. R.,
2. Sandle T.,
3. Tidswell E. C.
1. Denoya C. D.
Alternative Microbiological Methods and New Pharmaceutical Microbiology Curriculum. In Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices, 1st ed.; Saghee M. R., Sandle T., Tidswell E. C., Eds.; Business Horizons Pharmaceutical Publishers: New Delhi, India, 2010; Chapter 20, pp 491–518.
2.↵
World Health Organization. WHO Technical Report Series No. 961: Annex 6: WHO Good Manufacturing Practices for Sterile Pharmaceutical Products. WHO: Geneva, 2011; pp 263.
3.↵
Council of Europe. Alternative Methods for Control of Microbiological Quality, Chapter 5.1.6. In European Pharmacopoeia (Ph. Eur.) 9th Edition, Council of Europe: Strasbourg, France, 2017; pp 532–543.
4.↵
British Pharmacopoeia Commission. Alternative Methods for Control of Microbiological Quality. In: British Pharmacopoeia; TSO: London, 2019; Vol. V, Supplementary Chapter IV–K, pp A800–A810.
5.↵
Ministry of Health Labour and Welfare of Japan, Rapid Microbial Methods. In The Japanese Pharmacopoeia, 17th Edition (English Version), MHLW: Tokyo, 2016; pp 2507–2509.
6.↵
1. Pereault M.,
2. Alles S.,
3. Caballero O.,
4. Sarver R.,
5. McDougal S.,
6. Mozola M.,
7. Rice J.
Validation of the Soleris® Direct Yeast and Mold Method for Semiquantitative Determination of Yeast and Mold in a Variety of Foods. J. AOAC Int. 2014, 97 (4), 1084–1091.
OpenUrl
7.↵
1. Foti D.,
2. Romano L.,
3. Alles S.,
4. Mozola M. A.
Validation of the Soleris® E. coli Method for Detection and Semi-Quantitative Determination of Escherichia coli in Foods. J. AOAC Int. 2012, 95 (3), 786–794.
OpenUrl PubMed
8.↵
1. Alles S.,
2. McDougal S.,
3. Caballero O.,
4. Mozola M.,
5. Rice J.
Validation of a Minor Modification to the Soleris® Direct Yeast and Mold Vial and Selective Supplement. J. AOAC Int. 2015, 98 (5), 1286–1289.
OpenUrl
9.↵
1. Montei C.,
2. McDougal S.,
3. Mozola M.,
4. Rice J.
Semiquantitative Determination of Mesophilic, Aerobic Microorganisms in Cocoa Products Using the Soleris® NF-TVC Method. J. AOAC Int. 2014, 97 (1), 155–158.
OpenUrl
10.↵
1. Henriques J.,
2. Cardoso C.,
3. Vitorino C.
Rapid Microbiological Methods. They Are Rapid! Are They Fast? In Research Trends of Microbiology; MedDocs Publishers LLC., 2019.
11.↵
1. Miller M. J.
The Implementation of Rapid Microbiological Methods. Eur. Pharm. Rev. 2010, (5).
12.↵
1. Miller M. J.
Case Study of a New Growth-Based Rapid Microbiological Method (RMM) That Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count. Am. Pharm. Rev 2012, 15 (2), 18–25.
OpenUrl
13.↵
1. Clark C. L.,
2. Merritt A. M.,
3. Burrow J. A.,
4. Steible C. K.
Effect of Aluminum Hydroxide/Magnesium Hydroxide Antacid and Bismuth Subsalicylate on Gastric pH in Horses. J. Am. Vet. Med. Assoc. 1996, 208 (10), 1687–1691.
OpenUrl PubMed
14.↵
1. Hem S. L.,
2. White J. L.,
3. Buehler J. D.,
4. Luber J. R.,
5. Grim W. M.,
6. Lipka E. A.
Evaluation of Antacid Suspensions Containing Aluminum Hydroxide and Magnesium Hydroxide. Am. J. Hosp. Pharm. 1982, 39 (11), 1925–1930.
OpenUrl Abstract
15.↵
1. El-Serag H. B.,
2. Sweet S.,
3. Winchester C. C.,
4. Dent J.
Update on the Epidemiology of Gastro-Oesophageal Reflux Disease: A Systematic Review. Gut 2014, 63 (6), 871–880.
OpenUrl Abstract/FREE Full Text
16.↵
1. Eisen G.
The Epidemiology of Gastroesophageal Reflux Disease: What We Know and What We Need to Know. Am. J. Gastroenterol. 2001, 96 (8 Suppl), 16–18.
OpenUrl PubMed Web of Science
17.↵
1. Sontag S. J.
The Medical Management of Reflux Esophagitis. Role of Antacids and Acid Inhibition. Gastroenterol. Clin. North Am. 1990, 19 (3), 683–712.
OpenUrl PubMed Web of Science
18.↵
1. Mozola M.,
2. Gray L. R.,
3. Feldpausch J.,
4. Alles S.,
5. McDougal S.,
6. Montei C.,
7. Sarver R.,
8. Steiner B.,
9. Cooper C.,
10. Rice J.
Validation of the Soleris® NF-TVC Method for Determination of Total Viable Count in a Variety of Foods. J. AOAC Int. 2013, 96 (2), 399–403.
OpenUrl
19.↵
U.S. Pharmacopeial Convention, General Chapter <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparation and Substances for Pharmaceutical Use. In USP 43–NF 38 2S, USP: Rockville, MD, 2020.
20.↵
U.S. Pharmacopeial Convention, General Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. In USP 43–NF 38 2S, USP: Rockville, MD, 2020.
21.↵
1. Alles S.,
2. Shrestha N.,
3. Ellsworth A.,
4. Rider A.,
5. Foti D.,
6. Knickerbocker J.,
7. Mozola M.
Validation of the Soleris Yeast and Mold Test for Semiquantitative Determination of Yeast and Mold in Selected Foods. J. AOAC Int. 2009, 92 (5), 1396–1415.
OpenUrl PubMed
22.↵
1. Ritter A.
Análisis Microbiológicos Rápidos: Evaluación de Diferentes Métodos y Sus Aplicaciones. Pharm. Technol. 2014, 1 (1), 4–7.
OpenUrl
23.↵
1. Nemati M.,
2. Hamidi A.,
3. Maleki Dizaj S.,
4. Javaherzadeh V.,
5. Lotfipour F.
An Overview on Novel Microbial Determination Methods in Pharmaceutical and Food Quality Control. Adv. Pharm. Bull. 2016, 6 (3), 301–308.
OpenUrl
24.↵
U.S. Pharmacopeial Convention, General Chapter <1223> Validation of Alternative Microbiological Methods. In USP 43–NF 38 2S, USP: Rockville, MD, 2020.
25.↵
1. Limberg B. J.,
2. Johnstone K.,
3. Filloon T.,
4. Catrenich C.
Performance Equivalence and Validation of the Soleris Automated System for Quantitative Microbial Content Testing Using Pure Suspension Cultures. J. AOAC Int. 2016, 99 (5), 1331–1337.
OpenUrl
26.↵
1. Easter M. C.
1. Newby P. J.,
2. Johnson B.
Overview of Alternative Rapid Microbiological Methods. In Rapid Microbiological Methods in the Pharmaceutical Industry, Easter M. C., Ed.; CRC Press: Boca Raton, FL, 2003; pp 28–40.
27.↵
Parental Drug Association Inc. Technical Report No. 33: Evaluation, Validation and Implementation of Alternative and Rapid Microbial Methods; Bethesda, MD, 2013.
28.↵
U.S. Pharmacopeial Convention, General Chapter <1227>Validation of Microbial Recovery from Pharmacopeial Articles. In USP 43–NF 38 2S, USP: Rockville, MD, 2020.
29.↵
1. Matwiejczuk N.,
2. Galicka A.,
3. Brzóska M. M.
Review of the Safety of Application of Cosmetic Products Containing Parabens. J. Appl. Toxicol. 2020, 40 (1), 176–210.
OpenUrl
30.↵
Soleris Operator's Manual, Version 7.3; Neogen: Lansing, MI, 2014.
31.↵
1. McCormick P. J.,
2. Schoene M. J.,
3. Dehmler M. A.,
4. Kaiser J. J.,
5. Norton S. E.,
6. Pizon A.,
7. Fornalik M. A.
Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model. PDA J. Pharm. Sci. Technol. 2013, 67 (5), 512–532.
OpenUrl Abstract/FREE Full Text

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Keywords

[1] 1.↵
Saghee M. R.,
Sandle T.,
Tidswell E. C.
Denoya C. D.
Alternative Microbiological Methods and New Pharmaceutical Microbiology Curriculum. In Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices, 1st ed.; Saghee M. R., Sandle T., Tidswell E. C., Eds.; Business Horizons Pharmaceutical Publishers: New Delhi, India, 2010; Chapter 20, pp 491–518.

[2] Saghee M. R.,

[3] Sandle T.,

[4] Tidswell E. C.

[5] Denoya C. D.

[6] 2.↵
World Health Organization. WHO Technical Report Series No. 961: Annex 6: WHO Good Manufacturing Practices for Sterile Pharmaceutical Products. WHO: Geneva, 2011; pp 263.

[7] 3.↵
Council of Europe. Alternative Methods for Control of Microbiological Quality, Chapter 5.1.6. In European Pharmacopoeia (Ph. Eur.) 9th Edition, Council of Europe: Strasbourg, France, 2017; pp 532–543.

[8] 4.↵
British Pharmacopoeia Commission. Alternative Methods for Control of Microbiological Quality. In: British Pharmacopoeia; TSO: London, 2019; Vol. V, Supplementary Chapter IV–K, pp A800–A810.

[9] 5.↵
Ministry of Health Labour and Welfare of Japan, Rapid Microbial Methods. In The Japanese Pharmacopoeia, 17th Edition (English Version), MHLW: Tokyo, 2016; pp 2507–2509.

[10] 6.↵
Pereault M.,
Alles S.,
Caballero O.,
Sarver R.,
McDougal S.,
Mozola M.,
Rice J.
Validation of the Soleris® Direct Yeast and Mold Method for Semiquantitative Determination of Yeast and Mold in a Variety of Foods. J. AOAC Int. 2014, 97 (4), 1084–1091.
OpenUrl

[11] Pereault M.,

[12] Alles S.,

[13] Caballero O.,

[14] Sarver R.,

[15] McDougal S.,

[16] Mozola M.,

[17] Rice J.

[18] 7.↵
Foti D.,
Romano L.,
Alles S.,
Mozola M. A.
Validation of the Soleris® E. coli Method for Detection and Semi-Quantitative Determination of Escherichia coli in Foods. J. AOAC Int. 2012, 95 (3), 786–794.
OpenUrl PubMed

[19] Foti D.,

[20] Romano L.,

[21] Alles S.,

[22] Mozola M. A.

[23] 8.↵
Alles S.,
McDougal S.,
Caballero O.,
Mozola M.,
Rice J.
Validation of a Minor Modification to the Soleris® Direct Yeast and Mold Vial and Selective Supplement. J. AOAC Int. 2015, 98 (5), 1286–1289.
OpenUrl

[24] Alles S.,

[25] McDougal S.,

[26] Caballero O.,

[27] Mozola M.,

[28] Rice J.

[29] 9.↵
Montei C.,
McDougal S.,
Mozola M.,
Rice J.
Semiquantitative Determination of Mesophilic, Aerobic Microorganisms in Cocoa Products Using the Soleris® NF-TVC Method. J. AOAC Int. 2014, 97 (1), 155–158.
OpenUrl

[30] Montei C.,

[31] McDougal S.,

[32] Mozola M.,

[33] Rice J.

[34] 10.↵
Henriques J.,
Cardoso C.,
Vitorino C.
Rapid Microbiological Methods. They Are Rapid! Are They Fast? In Research Trends of Microbiology; MedDocs Publishers LLC., 2019.

[35] Henriques J.,

[36] Cardoso C.,

[37] Vitorino C.

[38] 11.↵
Miller M. J.
The Implementation of Rapid Microbiological Methods. Eur. Pharm. Rev. 2010, (5).

[39] Miller M. J.

[40] 12.↵
Miller M. J.
Case Study of a New Growth-Based Rapid Microbiological Method (RMM) That Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count. Am. Pharm. Rev 2012, 15 (2), 18–25.
OpenUrl

[41] Miller M. J.

[42] 13.↵
Clark C. L.,
Merritt A. M.,
Burrow J. A.,
Steible C. K.
Effect of Aluminum Hydroxide/Magnesium Hydroxide Antacid and Bismuth Subsalicylate on Gastric pH in Horses. J. Am. Vet. Med. Assoc. 1996, 208 (10), 1687–1691.
OpenUrl PubMed

[43] Clark C. L.,

[44] Merritt A. M.,

[45] Burrow J. A.,

[46] Steible C. K.

[47] 14.↵
Hem S. L.,
White J. L.,
Buehler J. D.,
Luber J. R.,
Grim W. M.,
Lipka E. A.
Evaluation of Antacid Suspensions Containing Aluminum Hydroxide and Magnesium Hydroxide. Am. J. Hosp. Pharm. 1982, 39 (11), 1925–1930.
OpenUrl Abstract

[48] Hem S. L.,

[49] White J. L.,

[50] Buehler J. D.,

[51] Luber J. R.,

[52] Grim W. M.,

[53] Lipka E. A.

[54] 15.↵
El-Serag H. B.,
Sweet S.,
Winchester C. C.,
Dent J.
Update on the Epidemiology of Gastro-Oesophageal Reflux Disease: A Systematic Review. Gut 2014, 63 (6), 871–880.
OpenUrl Abstract/FREE Full Text

[55] El-Serag H. B.,

[56] Sweet S.,

[57] Winchester C. C.,

[58] Dent J.

[59] 16.↵
Eisen G.
The Epidemiology of Gastroesophageal Reflux Disease: What We Know and What We Need to Know. Am. J. Gastroenterol. 2001, 96 (8 Suppl), 16–18.
OpenUrl PubMed Web of Science

[60] Eisen G.

[61] 17.↵
Sontag S. J.
The Medical Management of Reflux Esophagitis. Role of Antacids and Acid Inhibition. Gastroenterol. Clin. North Am. 1990, 19 (3), 683–712.
OpenUrl PubMed Web of Science

[62] Sontag S. J.

[63] 18.↵
Mozola M.,
Gray L. R.,
Feldpausch J.,
Alles S.,
McDougal S.,
Montei C.,
Sarver R.,
Steiner B.,
Cooper C.,
Rice J.
Validation of the Soleris® NF-TVC Method for Determination of Total Viable Count in a Variety of Foods. J. AOAC Int. 2013, 96 (2), 399–403.
OpenUrl

[64] Mozola M.,

[65] Gray L. R.,

[66] Feldpausch J.,

[67] Alles S.,

[68] McDougal S.,

[69] Montei C.,

[70] Sarver R.,

[71] Steiner B.,

[72] Cooper C.,

[73] Rice J.

[74] 19.↵
U.S. Pharmacopeial Convention, General Chapter <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparation and Substances for Pharmaceutical Use. In USP 43–NF 38 2S, USP: Rockville, MD, 2020.

[75] 20.↵
U.S. Pharmacopeial Convention, General Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. In USP 43–NF 38 2S, USP: Rockville, MD, 2020.

[76] 21.↵
Alles S.,
Shrestha N.,
Ellsworth A.,
Rider A.,
Foti D.,
Knickerbocker J.,
Mozola M.
Validation of the Soleris Yeast and Mold Test for Semiquantitative Determination of Yeast and Mold in Selected Foods. J. AOAC Int. 2009, 92 (5), 1396–1415.
OpenUrl PubMed

[77] Alles S.,

[78] Shrestha N.,

[79] Ellsworth A.,

[80] Rider A.,

[81] Foti D.,

[82] Knickerbocker J.,

[83] Mozola M.

[84] 22.↵
Ritter A.
Análisis Microbiológicos Rápidos: Evaluación de Diferentes Métodos y Sus Aplicaciones. Pharm. Technol. 2014, 1 (1), 4–7.
OpenUrl

[85] Ritter A.

[86] 23.↵
Nemati M.,
Hamidi A.,
Maleki Dizaj S.,
Javaherzadeh V.,
Lotfipour F.
An Overview on Novel Microbial Determination Methods in Pharmaceutical and Food Quality Control. Adv. Pharm. Bull. 2016, 6 (3), 301–308.
OpenUrl

[87] Nemati M.,

[88] Hamidi A.,

[89] Maleki Dizaj S.,

[90] Javaherzadeh V.,

[91] Lotfipour F.

[92] 24.↵
U.S. Pharmacopeial Convention, General Chapter <1223> Validation of Alternative Microbiological Methods. In USP 43–NF 38 2S, USP: Rockville, MD, 2020.

[93] 25.↵
Limberg B. J.,
Johnstone K.,
Filloon T.,
Catrenich C.
Performance Equivalence and Validation of the Soleris Automated System for Quantitative Microbial Content Testing Using Pure Suspension Cultures. J. AOAC Int. 2016, 99 (5), 1331–1337.
OpenUrl

[94] Limberg B. J.,

[95] Johnstone K.,

[96] Filloon T.,

[97] Catrenich C.

[98] 26.↵
Easter M. C.
Newby P. J.,
Johnson B.
Overview of Alternative Rapid Microbiological Methods. In Rapid Microbiological Methods in the Pharmaceutical Industry, Easter M. C., Ed.; CRC Press: Boca Raton, FL, 2003; pp 28–40.

[99] Easter M. C.

[100] Newby P. J.,

[101] Johnson B.

[102] 27.↵
Parental Drug Association Inc. Technical Report No. 33: Evaluation, Validation and Implementation of Alternative and Rapid Microbial Methods; Bethesda, MD, 2013.

[103] 28.↵
U.S. Pharmacopeial Convention, General Chapter <1227>Validation of Microbial Recovery from Pharmacopeial Articles. In USP 43–NF 38 2S, USP: Rockville, MD, 2020.

[104] 29.↵
Matwiejczuk N.,
Galicka A.,
Brzóska M. M.
Review of the Safety of Application of Cosmetic Products Containing Parabens. J. Appl. Toxicol. 2020, 40 (1), 176–210.
OpenUrl

[105] Matwiejczuk N.,

[106] Galicka A.,

[107] Brzóska M. M.

[108] 30.↵
Soleris Operator's Manual, Version 7.3; Neogen: Lansing, MI, 2014.

[109] 31.↵
McCormick P. J.,
Schoene M. J.,
Dehmler M. A.,
Kaiser J. J.,
Norton S. E.,
Pizon A.,
Fornalik M. A.
Evaluation of a Rapid Microbiological Method with a Mixed Culture Biofilm Model. PDA J. Pharm. Sci. Technol. 2013, 67 (5), 512–532.
OpenUrl Abstract/FREE Full Text

[110] McCormick P. J.,

[111] Schoene M. J.,

[112] Dehmler M. A.,

[113] Kaiser J. J.,

[114] Norton S. E.,

[115] Pizon A.,

[116] Fornalik M. A.

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