Detection of indicator pathogens from pharmaceutical finished products and raw materials using multiplex PCR and comparison with conventional microbiological methods

Journal of Industrial Microbiology and Biotechnology

Volumn 35, Issue 9, 2008, Pages 1007-1018

  Karanam, Venkateswara Rao ^a   Reddy, Haranatha P ^b   Subba Raju, B V ^c   Rao, Juvva Chandra ^c   Kavikishore, P B ^d   Vijayalakshmi, M ^a  

^a ACHARYA NAGARJUNA UNIVERSITY   (India)

^b Indo American Cancer Institute and Research Centre   (India)

^c CNR Complex   (India)

^d OSMANIA UNIVERSITY   (India)

Author keywords

Escherichia coli; Indicator pathogens; PCR; Pharmaceuticals; Pseudomonas aeruginosa; Salmonella spp.; Staphylococcus aureus; USP

Indexed keywords

MESSENGER RNA; NUCLEASE; RIBOSOME RNA;

AMPLICON; ARTICLE; BACTERIAL VIRULENCE; CONTROLLED STUDY; ESCHERICHIA COLI; GENE AMPLIFICATION; MICROBIAL CONTAMINATION; MICROBIOLOGICAL EXAMINATION; MULTIPLEX POLYMERASE CHAIN REACTION; NONHUMAN; PSEUDOMONAS AERUGINOSA; SALMONELLA; STAPHYLOCOCCUS AUREUS;

BACTERIA; BACTERIOLOGICAL TECHNIQUES; DNA, BACTERIAL; DRUG CONTAMINATION; GENES, BACTERIAL; INDUSTRIAL MICROBIOLOGY; MOLECULAR SEQUENCE DATA; POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY;

BACTERIA (MICROORGANISMS); ESCHERICHIA COLI; PSEUDOMONAS AERUGINOSA; SALMONELLA; STAPHYLOCOCCUS AUREUS;

EID: 50249108933     PISSN: 13675435     EISSN: 14765535     Source Type: Journal    
DOI: 10.1007/s10295-008-0376-z     Document Type: Article

References (44)

1. DCJ Basset KJ Stokes WRG Thomas 1970 Wound infections due to Pseudomonas multivorans. A water-borne contaminant of disinfectant solutions Lancet 1 1188 1191 10.1016/S0140-6736(70)91783-6
2. RL Berkelman RL Anderson BJ Davis AK Highsmith NJ Petersen WW Bono 1984 Intrinsic bacterial contamination of a commercial iodophor solution Appl Environ Microbiol 47 752 756
3. CW Brasher A Depaola DD Jones AK Bej 1998 Detection of microbial pathogens in shellfish with multiplex PCR Curr Microbiol 37 101 107 10.1007/s002849900346
4. W Casey H Muth J Kirby P Allen 1998 Use of nonselective preenrichment media for the recovery of enteric bacteria from pharmaceutical products Pharm Technol 22 114 117
5. AF Desvignes J Bernard G Campion 1973 Etude de la contaminacion microbienne de diverses preparations pharmaceutiques Ann Pharm Fr 23 775 785
6. Flickinger B (2000) Making dollars and sense with rapid microbiology. Pharm Qual April/May:22-28
7. EJG Glencross 1972 Pancreatin as a source of hospital acquired salmonellosis BMJ 2 376 378
8. PA Gouws M Visser VS Brszel 1998 A polymerase chain reaction procedure for the detection of Salmonella spp. within 24 hours J Food Prot 61 1039 1042
9. O Henegariu NR Heerema SR Dlouhy GH Vance PH Vogt 1997 Multiplex PCR: critical parameters and step-by-step protocol Biotechniques 23 504 511
10. S Hills 1946 The isolation of Clostridium tetani from infected talc Newzealand Med J 45 419 423
11. WE Hill 1996 The polymerase chain reaction: applications for the detection of food borne pathogens Crit Rev Food Sci Nutr 36 1-2 123 173
12. R Ignar D English L Jimenez 1998 Rapid detection of microbial contamination in triclosan and high fluoride denitrifices using an ATP bioluminescence assay J Rapid Methods Autom Microbiol 6 51 58 10.1111/j.1745-4581.1998.tb00183.x
13. L Jimenez S Smalls C Scalici Y Bosko R Ignar D English 1998 Detection of Salmonella spp., contamination in raw materials and pharmaceutical products using the BAX TM system, a PCR assay J Rapid Methods Autom Microbiol 6 67 76 10.1111/j.1745-4581.1998.tb00185.x
14. L Jimenez R Ignar S Smalls J Grech Hamilton Y Bosko D English 1999 Molecular detection of bacterial indicators in cosmetic/pharmaceutical samples J Ind Microbiol Biotechnol 21 93 95 10.1038/sj.jim.2900611
15. L Jimenez 2001 Simultaneous PCR detection of a bacteria and mold DNA sequences in pharmaceutical samples by using a gradient thermocycler J Rapid Methods Autom Microbiol 9 263 270 10.1111/j.1745-4581.2001.tb00252.x
16. L Jimenez C Scalici S Smalls Y Bosko R Ignar 2001 PCR detection of Salmonella typhimurium in Pharmaceutical raw materials and products Contaminated with a mixed bacterial culture using the BAX™ system PDA J Pharm Sci Technol 55 286 289
17. KL Josephson CP Gerba IL Pepper 1993 Polymerase chain reaction detection of nonviable bacterial pathogens Appl Environ Microbiol 59 3513 3515
18. LO Kallings O Ringertz L Silverstolpe 1966 Microbiological contamination of medical preparations Acta Pharmaceu Suet 3 219 228
19. DB Knabbel RL Crawford 1995 Extraction and purification of microbial DNA from petroleum-contaminated soils and detection of low numbers of toluene, octane, and pesticide degraders by multiplex polymerase chain reaction and Southern analysis Mol Ecol 4 579 591 10.1111/j.1365-294X.1995.tb00258.x
20. AK Lampel PA Orlandi L Kornegay 2000 Improved template preparationfor PCR-based assays for detection of food-borne bacterial pathogens Appl Environ Microbiol 66 4539 4542 10.1128/AEM.66.10.4539-4542.2000
21. DJ Lang LS Kunz AR Martin SA Schroeder LA Thomson 1967 Carmine as a source of nosocomial salmonellosis N Engl J Med 276 829 832
22. J Mahon CK Murphey PW Jones PA Barrow 1994 Comparison of multiplex PCR and standard bacteriological methods of detecting Salmonella on chicken skin Lett Appl Microbiol 19 169 172 10.1111/j.1472-765X.1994.tb00934.x
23. JB Mahony KE Luinstra M Tyndall JW Sellors J Krepel M Chernesky 1995 Multiplex PCR for detection of Chlamydia trachomatis and Nesseria gonorrhoeae in genitourinary specimens J Clin Microbiol 33 3049 3053
24. Martinez-Bermudez A, Rodriguez de Lecea J, Soto-Esteras T, Vazquez-Estevez C, Chena-Canete C (1991) Tipos de contaminantes microbianos de materias primas farmaceuticas. Rev Latinoam Microbiol 33:153-157
25. LW Mestrandrea 1997 Microbiological monitoring of environmental conditions for nonsterile pharmaceutical manufacturing Pharmaceu Technol 21 59 74
26. RG Mitchell AC Hayward 1966 Postoperative urinary tract infection caused by contaminating irrigation fluid Lancet 9i 793 795 10.1016/S0140-6736(66) 91866-6
27. DS Orth 1989 Microbiological considerations in cosmetic formula development and evaluation. I. Microbiological quality of a product Cosmet Toilet 104 49 64
28. MJ Palmieri SL Carito RF Meyer 1988 Comparison of rapid NFT and API 20E with conventional methods for identification of gram-negative nonfermentative bacilli from pharmaceuticals and cosmetics Appl Environ Microbiol 54 2838 2841
29. PDA (2000) "Evaluation, validation, and implementation of new microbiological testing methods," PDA Technical Report #33. PDA J Pharmaceu Sci and Technol 54
30. P Phuektes PD Mansell GF Browning 2001 Multiplex polymerase chain reaction assay for Simultaneous detection of S. aureus and streptococcal causes of bovine mastitis J Dairy Sci 84 1140 1148
31. B Ray 1986 Impact of bacterial injury and repair in food microbiology: Its past, present and future J Food Prot 49 651 655
32. Read RB (1984) Bacteriological analytical manual. 6th ed:1-19
33. Russell M (1988) Microbiological control of raw materials. In: Bloomfield SF, Baird R, Lear RE, Leech R (eds) Microbial quality assurance in pharmaceuticals, Cosm and Toiletries. Ellis Horwood, Chichester, pp 35-48
34. TJ Safranek WR Jatvis LA Carson LB Cusick VA Silcox 1987 Mycobacterium chelonae wound infections after plastic surgery employing contaminated gentiane violet skin marking solutions N Engl J Med 317 197 201
35. Sutton SVW, Magee MA, Brannan DK (1997) Cosmetic microbiology, A practical handbook. In: Brannan DK (ed), CRC Press, New York pp 96-122
36. Underwood E (1992) Ecology of microorganisms as it affects the pharmaceutical industry. In: Hugo WB, Russell AD (eds) Pharmaceu Microbiol. Blackwell, Oxford, pp 353-368
37. Underwood E (1998) Pharmaceutical Microbiology, 6th edn. In: Hugo WB, Russel AD (eds) Blackwell Science, Oxford, pp 339-354
38. U.S Pharmacopeial Convention Inc. (1985) The United States pharmacopeia XXI revision and the national formulary, 16th edn., p 1151-1156
39. United States Pharmacopeial Convention (2000) Microbial test limits, In: U.S. Pharmacopoeia. United States Pharmacopeial Convention, Rockville, 24:1814-1818
40. H Van Der Zee JH Huis in't Veld 1997 Rapid and alternative screening methods for microbiological analysis J AOAC 80 934 940
41. AS Waage T Vardund V Lund G Kapperud 1999 Detection of small numbers of Campylobacter jejuni and Campylobacter coli cells in environmental water, sewage, and food samples by a seminested PCR assay Appl Environ Microbiol 65 1636 1643
42. IG Wilson 1997 Inhibition and facilitation of nucleic acid ampli®cation Appl Environ Microbiol 63 3741 3751
43. DK Winters MF Slavik 1995 Evaluation of a PCR-based assay for specific detection of Campylobacter jejuni in chicken washes Mol Cell Probes 9 307 310 10.1016/S0890-8508(95) 91556-7
44. DK Winters AE O'Leary MF Slavik 1998 Polymerase chain reaction for rapid Detection Of Campylobacter jejuni in artificially contaminated foods Lett Appl Microbiol 27 163 167 10.1046/j.1472-765X.1998.00411.x