Examination of Glass Particulate Contamination after Ampoule Breakage
-
Motahhareh Mojarradi
,
Kaveh Kazemian
,
Amirhossein Ghanbarzamani
,
Solmaz Ghaffari
,
Maryam Shiehmorteza
Abstract
Background: Administering injectable medicines is an invasive procedure with potential risks, including unintentional contamination of the content by glass particles during ampoule preparation by the healthcare team. Injection of medication contaminated with microscopic particles into patients can cause serious adverse effects depending on the route of administration and particle size. This study aimed to evaluate the relationship between nurse gender, work experience, ampoule breaking method, and ampoule volume with the number and size of probable glass particles after breaking ampoules.
Methods: A total of 183 ampoules (2 ml, 5 ml, and 10 ml) were studied. Thirty male and female nurses participated, who were categorized into three groups based on work experience: 1–5 years, 5–10 years, and over 10 years. The size and number of glass particles were examined using a dynamic light scattering (DLS) system. The morphological characteristics of the particles were further studied using inverted microscopy.
Results: On average, 53.49% of the particles in the solution of the broken ampoules were greater than 10 μm in size. Additionally, 17.65% showed a size greater than 25 μm. The particle size ranged from 14.39 μm to 184 μm. The average size of glass particles was 42.65 μm in the 2 ml ampoules, 32.13 μm in the 5 ml ampoules, and 42.72 μm in the 10 ml ampoules.
Conclusion: Based on the findings, the percentage of glass particles entering the ampoule's solution upon breaking is not influenced by individual nurse characteristics. Instead, it depends on the ampoule volume, with smaller volumes associated with a higher proportion of particles larger than 10 μm and 25 μm. While the average particle size tends to decrease as nurses’ work experience increases, smaller ampoules generally contain larger particles. However, the methods used by nurses to break the ampoule do not significantly affect particle size.
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[3] Pareek V, Khunteta A. Pharmaceutical packaging: current trends and future. Int J Pharm Pharm Sci. 2014; 6(6):480-5.
[4] Lockhart H, Paine FA. Packaging of pharmaceuticals and healthcare products. Springer Science & Business Media; 1996.
[5] Zadbuke N, Shahi S, Gulecha B, Padalkar A, Thube M. Recent trends and future of pharmaceutical packaging technology. J Pharm Bioallied Sci. 2013; 5(2):98-110.
[6] Pal R, Pandey P, Kant Thakur S, Khadam VK, Dutta P, Arushi SC, et al. The significance of pharmaceutical packaging and materials in addressing challenges related to unpacking pharmaceutical products. Int J Pharm Healthc Innov. 2024; 1(3):149-73.
[7] Esfahanian S. Implementing Artificial Intelligence in the Evaluation of Packaging Distribution and Label Design Modeling [dissertation]. East Lansing (MI): Michigan State University; 2024.
[8] Pillai SA, Chobisa D, Urimi D, Ravindra N. Pharmaceutical glass interactions: a review of possibilities. J Pharm Sci Res. 2016; 8(2):103.
[9] Dean DA, Evans ER, Hall IH, editors. Pharmaceutical packaging technology. Boca Raton (FL): CRC Press; 2005.
[10] Ibrahim ID, Hamam Y, Sadiku ER, Ndambuki JM, Kupolati WK, Jamiru T, et al. Need for sustainable packaging: an overview. Polymers (Basel). 2022; 14(20):4430.
[11] Schaut RA, Weeks WP. Historical review of glasses used for parenteral packaging. PDA J Pharm Sci Technol. 2017; 71(4):279-96.
[12] Guadagnino E, Guglielmi M, Nicoletti F. Glass: The best material for pharmaceutical packaging. Int J Appl Glass Sci. 2022; 13(3):281-91.
[13] Hirano M, Ishii A, Ueda N, Inoue Y, Miyajima M, Tomita K, et al. Analysis of upper-limb movements to open glass ampoules and training methods in nursing education. J Biomech Sci Eng. 2019; 14(2):19-00037.
[14] Nasa P. A review on pharmaceutical packaging material. World J Pharm Res. 2014; 3(5):344-68.
[15] Heiss-Harris GM, Verklan MT. Maximizing patient safety: filter needle use with glass ampules. J Perinat Neonatal Nurs. 2005; 19(1):74-81.
[16] Caudron E, Tfayli A, Monnier C, Manfait M, Prognon P, Pradeau D. Identification of hematite particles in sealed glass containers for pharmaceutical uses by Raman microspectroscopy. J Pharm Biomed Anal. 2011; 54(4):866-8.
[17] Shaw N, Lyall E. Hazards of glass ampoules. BMJ. 1985; 291(6506):1390.
[18] Carbone-Traber KB, Shanks CA. Glass particle contamination in single-dose ampules. Anesth Analg. 1986; 65(12):1361-3.
[19] Preston ST, Hegadoren K. Glass contamination in parenterally administered medication. J Adv Nurs. 2004; 48(3):266-70.
[20] Joo GE, Sohng KY, Park MY. The effect of different methods of intravenous injection on glass particle contamination from ampules. SpringerPlus. 2016; 5(1):15.
[21] Carraretto AR, Curi EF, Almeida CE, Abatti RE. Glass ampoules: risks and benefits. Rev Bras Anestesiol. 2011; 61:517-21.
[22] Sabon Jr RL, Cheng EY, Stommel KA, Hennen CR. Glass particle contamination: influence of aspiration methods and ampule types. Anesthesiology. 1989; 70(5):859-62.
[23] Lye ST, Hwang NC. Glass particle contamination: is it here to stay?. Anaesthesia. 2003; 58(1).
[24] Kempen PM, Sulkowski E, Sawyer RA. Glass ampules and associated hazards. Crit Care Med. 1989; 17(8):812-3.
[25] Furgang FA. Glass particles in ampules. Anesthesiology. 1974; 41(5):525.
[26] Kawasaki Y, Matsuka N, Okada T, Kawashima R, Kitagawa N, Sendo T, et al. Examination of Particulate Contamination after Opening Ampoules-Relationship between Ampoule Inner-diameter and Glass Particle Accumulation after Opening Ampoules. Iryo Yakugaku (J Pharm Health Care Sci). 2008; 34(11):1032-6.
[27] Kumari S, Agarwal S, Khan S. Micro/nano glass pollution as an emerging pollutant in near future. J Hazard Mater Adv. 2022; 6:100063.
[28] Söğüt NN, Erkoç A. Glass Particle Contamination and Using the Filter Needle: A Cross-sectional Study. Turk J Sci Health. 2024; 5(2):68-77.
[29] Erkoc Hut A, Yazici ZA. Glass particle contamination threat in nursing practice: A pilot study. J Adv Nurs. 2021; 77(7):3189-91.
[30] Hut AE, Bayır Y. Cam ilaç ampullerinde tehlike: kıymık şeklinde cam parçacıklar. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi. 2017; 6(3):105-10.
[31] Lee KR, Chae YJ, Cho SE, Chung SJ. A strategy for reducing particulate contamination on opening glass ampoules and development of evaluation methods for its application. Drug Dev Ind Pharm. 2011; 37(12):1394-401.
[32] Turco S, Davis NM. Glass particles in intravenous injections. N Engl J Med. 1972; 287(23):1204-5.
[33] Bohrer D, do Nascimento PC, Binotto R, Pomblum SC. Influence of the glass packing on the contamination of pharmaceutical products by aluminum. Part I: Salts, glucose, heparin and albumin. J Trace Elem Med Biol. 2001; 15(2-3):95-101.
[34] Glube ML, Littleford J, Armour S. Paint chips and glass ampoules. Can J Anesth. 2000; 47(6):601-2.
[35] Ernerot L, Dahlinder L. The contamination of ampoules in connection with opening. Acta Pharm Suec. 1969; 6(3):401-6.
[36] Dorris GG, Bivins BA, Rapp RP, Weiss DL, DeLuca PP, Ravin MB. Inflammatory potential of foreign particulates in parenteral drugs. Anesth Analg. 1977; 56(3):422-7.
[37] Katz H, Borden H, Hirscher D. Glass-particle contamination of color-break ampules. Anesthesiology. 1973; 39(3):354.
[38] Keen M. Adverse effects of frequent intramuscular injections. Focus Crit Care. 1983; 10(4):15-6.
[39] Gillies IR, Thiel WJ, Oppenheim RC. Particulate contamination of Australian ampoules. J Pharm Pharmacol. 1986; 38(2):87-92.
[40] Hemingway CJ, Malhotra S, Almeida M, Azadian B, Yentis SM. The effect of alcohol swabs and filter straws on reducing contamination of glass ampoules used for neuroaxial injections. Anaesthesia. 2007; 62(3):286-8.
[41] Stehbens WE, Florey HW. The Behaviour of Intravenously Injected Particles Observed in Chambers in Rabbits'ears. Q J Exp Physiol Cogn Med Sci. 1960; 45(3):252-64.
[42] Lockhart JD. The medical significance of particulate matter in large volume parenteral solutions. In: National Symposium Proceedings. Safety of large volume parenteral solutions. 1966. p. 28. FDA.
[43] Garvan JM, Gunner BW. The harmful effects of particles in intravenous fluids. Med J Aust. 1964; 2(1):1-6.
[44] Michaels L, Poole RW. Injection granuloma of the buttock. Can Med Assoc J. 1970; 102(6):626.
[45] Belanger-Annable MC. Long-acting neuroleptics: technique for intramuscular injection. Can Nurse. 1985; 81(8):41-3.
[46] Hay J. Complications at site of injection of depot neuroleptics. BMJ. 1995; 311(7002):421.
[47] Brewer JH, Dunning JF. An in vitro and in vivo study of glass particles in ampules. J Am Pharm Assoc (Sci Ed). 1947; 36(10):289-93.
[48] Yorioka K, Oie S, Kamiya A. Comparison of particulate contamination in glass and plastic ampoules of glycyrrhizin injections after ampoule cutting. J Food Drug Anal. 2009; 17(3):3.
[49] Fry L. Glass micro-particulate contamination of intravenous drugs—should we be using filter needles? Aust Med Stud J. 2015; 6(1).
[50] Zabir AF, Choy CY, Rushdan R. Glass particle contamination of parenteral preparations of intravenous drugs in anaesthetic practice. S Afr J Anaesth Analg. 2008; 14(3):17-9.
[51] United States Pharmacopeial Convention. United States Pharmacopeia and National Formulary (USP 35–NF 30). Rockville (MD): United States Pharmacopeial Convention; 2012.
[52] Unahalekhaka A, Nuthong P, Geater A. Glass particles contamination in single dose ampoules: patient safety concern. Am J Infect Control. 2009; 37(5):E109-E110.
[53] Chiannilkulchai N, Kejkornkaew S. Safety concerns with glass particle contamination: improving the standard guidelines for preparing medication injections. Int J Qual Health Care. 2021; 33(2):mzab091.
[54] Craven RF, Hirnle CJ. Fundamentals of Nursing. 6th ed. Wolters Kluwer/Lippincott Williams & Wilkins; 2009.
[55] Timmons CL, Liu CY, Merkle S. Particulate generation mechanisms during bulk filling and mitigation via new glass vial. PDA J Pharm Sci Technol. 2017; 71(5):379-92.
[56] Bukofzer S, Ayres J, Chavez A, Devera M, Miller J, Ross D, et al. Industry perspective on the medical risk of visible particles in injectable drug products. PDA J Pharm Sci Technol. 2015; 69(1):123-39.
[57] Langille SE. Particulate matter in injectable drug products. PDA J Pharm Sci Technol. 2013; 67(3):186-200.
[58] Jack T, Brent BE, Boehne M, Müller M, Sewald K, Braun A, et al. Analysis of particulate contaminations of infusion solutions in a pediatric intensive care unit. Intensive Care Med. 2010; 36(4):707–711.
[59] Puntis JW, Wilkins KM, Ball PA, Rushton DI, Booth IW. Hazards of parenteral treatment: do particles count?. Arch Dis Child. 1992; 67(12):1475-7.
[60] Turco SJ, Davis NM. Detrimental effects of particulate matter on the pulmonary circulation. Jama. 1971; 217(1):81-2.
[61] Perez M, Décaudin B, Abou Chahla W, Nelken B, Barthelemy C, Lebuffe G, et al. In vitro analysis of overall particulate contamination exposure during multidrug IV therapy: impact of infusion sets. Pediatr Blood Cancer. 2015; 62(6):1042-7.
[62] Lofthus RM, Srebnik HH. The Physical Dimensions of the Human Neonatal Cardiovascular System. J Biomech Eng. 1987; 109(4):336–339.
[63] Heyman S. Toxicity and safety factors associated with lung perfusion studies with radiolabeled particles. J Nucl Med. 1979; 20(10):1098-9.
[64] Kienle PC, McElhiney LF, Kastango ES, Murdaugh LB, McCollum D, Power LA. ASHP guidelines on compounding sterile preparations. Am J Health Syst Pharm. 2014; 71(2):145–66.
[65] Yorioka K, Oie S, Oomaki M, Imamura A, Kamiya A. Particulate and microbial contamination in in-use admixed intravenous infusions. Biol Pharm Bull. 2006; 29(11):2321–3.
[2] Amarji B, Kulkarni A, Deb PK, Maheshwari R, Tekade RK. Package development of pharmaceutical products: Aspects of packaging materials used for pharmaceutical products. In: Dosage Form Design Parameters. Academic Press; 2018. p. 521-552.
[3] Pareek V, Khunteta A. Pharmaceutical packaging: current trends and future. Int J Pharm Pharm Sci. 2014; 6(6):480-5.
[4] Lockhart H, Paine FA. Packaging of pharmaceuticals and healthcare products. Springer Science & Business Media; 1996.
[5] Zadbuke N, Shahi S, Gulecha B, Padalkar A, Thube M. Recent trends and future of pharmaceutical packaging technology. J Pharm Bioallied Sci. 2013; 5(2):98-110.
[6] Pal R, Pandey P, Kant Thakur S, Khadam VK, Dutta P, Arushi SC, et al. The significance of pharmaceutical packaging and materials in addressing challenges related to unpacking pharmaceutical products. Int J Pharm Healthc Innov. 2024; 1(3):149-73.
[7] Esfahanian S. Implementing Artificial Intelligence in the Evaluation of Packaging Distribution and Label Design Modeling [dissertation]. East Lansing (MI): Michigan State University; 2024.
[8] Pillai SA, Chobisa D, Urimi D, Ravindra N. Pharmaceutical glass interactions: a review of possibilities. J Pharm Sci Res. 2016; 8(2):103.
[9] Dean DA, Evans ER, Hall IH, editors. Pharmaceutical packaging technology. Boca Raton (FL): CRC Press; 2005.
[10] Ibrahim ID, Hamam Y, Sadiku ER, Ndambuki JM, Kupolati WK, Jamiru T, et al. Need for sustainable packaging: an overview. Polymers (Basel). 2022; 14(20):4430.
[11] Schaut RA, Weeks WP. Historical review of glasses used for parenteral packaging. PDA J Pharm Sci Technol. 2017; 71(4):279-96.
[12] Guadagnino E, Guglielmi M, Nicoletti F. Glass: The best material for pharmaceutical packaging. Int J Appl Glass Sci. 2022; 13(3):281-91.
[13] Hirano M, Ishii A, Ueda N, Inoue Y, Miyajima M, Tomita K, et al. Analysis of upper-limb movements to open glass ampoules and training methods in nursing education. J Biomech Sci Eng. 2019; 14(2):19-00037.
[14] Nasa P. A review on pharmaceutical packaging material. World J Pharm Res. 2014; 3(5):344-68.
[15] Heiss-Harris GM, Verklan MT. Maximizing patient safety: filter needle use with glass ampules. J Perinat Neonatal Nurs. 2005; 19(1):74-81.
[16] Caudron E, Tfayli A, Monnier C, Manfait M, Prognon P, Pradeau D. Identification of hematite particles in sealed glass containers for pharmaceutical uses by Raman microspectroscopy. J Pharm Biomed Anal. 2011; 54(4):866-8.
[17] Shaw N, Lyall E. Hazards of glass ampoules. BMJ. 1985; 291(6506):1390.
[18] Carbone-Traber KB, Shanks CA. Glass particle contamination in single-dose ampules. Anesth Analg. 1986; 65(12):1361-3.
[19] Preston ST, Hegadoren K. Glass contamination in parenterally administered medication. J Adv Nurs. 2004; 48(3):266-70.
[20] Joo GE, Sohng KY, Park MY. The effect of different methods of intravenous injection on glass particle contamination from ampules. SpringerPlus. 2016; 5(1):15.
[21] Carraretto AR, Curi EF, Almeida CE, Abatti RE. Glass ampoules: risks and benefits. Rev Bras Anestesiol. 2011; 61:517-21.
[22] Sabon Jr RL, Cheng EY, Stommel KA, Hennen CR. Glass particle contamination: influence of aspiration methods and ampule types. Anesthesiology. 1989; 70(5):859-62.
[23] Lye ST, Hwang NC. Glass particle contamination: is it here to stay?. Anaesthesia. 2003; 58(1).
[24] Kempen PM, Sulkowski E, Sawyer RA. Glass ampules and associated hazards. Crit Care Med. 1989; 17(8):812-3.
[25] Furgang FA. Glass particles in ampules. Anesthesiology. 1974; 41(5):525.
[26] Kawasaki Y, Matsuka N, Okada T, Kawashima R, Kitagawa N, Sendo T, et al. Examination of Particulate Contamination after Opening Ampoules-Relationship between Ampoule Inner-diameter and Glass Particle Accumulation after Opening Ampoules. Iryo Yakugaku (J Pharm Health Care Sci). 2008; 34(11):1032-6.
[27] Kumari S, Agarwal S, Khan S. Micro/nano glass pollution as an emerging pollutant in near future. J Hazard Mater Adv. 2022; 6:100063.
[28] Söğüt NN, Erkoç A. Glass Particle Contamination and Using the Filter Needle: A Cross-sectional Study. Turk J Sci Health. 2024; 5(2):68-77.
[29] Erkoc Hut A, Yazici ZA. Glass particle contamination threat in nursing practice: A pilot study. J Adv Nurs. 2021; 77(7):3189-91.
[30] Hut AE, Bayır Y. Cam ilaç ampullerinde tehlike: kıymık şeklinde cam parçacıklar. Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi. 2017; 6(3):105-10.
[31] Lee KR, Chae YJ, Cho SE, Chung SJ. A strategy for reducing particulate contamination on opening glass ampoules and development of evaluation methods for its application. Drug Dev Ind Pharm. 2011; 37(12):1394-401.
[32] Turco S, Davis NM. Glass particles in intravenous injections. N Engl J Med. 1972; 287(23):1204-5.
[33] Bohrer D, do Nascimento PC, Binotto R, Pomblum SC. Influence of the glass packing on the contamination of pharmaceutical products by aluminum. Part I: Salts, glucose, heparin and albumin. J Trace Elem Med Biol. 2001; 15(2-3):95-101.
[34] Glube ML, Littleford J, Armour S. Paint chips and glass ampoules. Can J Anesth. 2000; 47(6):601-2.
[35] Ernerot L, Dahlinder L. The contamination of ampoules in connection with opening. Acta Pharm Suec. 1969; 6(3):401-6.
[36] Dorris GG, Bivins BA, Rapp RP, Weiss DL, DeLuca PP, Ravin MB. Inflammatory potential of foreign particulates in parenteral drugs. Anesth Analg. 1977; 56(3):422-7.
[37] Katz H, Borden H, Hirscher D. Glass-particle contamination of color-break ampules. Anesthesiology. 1973; 39(3):354.
[38] Keen M. Adverse effects of frequent intramuscular injections. Focus Crit Care. 1983; 10(4):15-6.
[39] Gillies IR, Thiel WJ, Oppenheim RC. Particulate contamination of Australian ampoules. J Pharm Pharmacol. 1986; 38(2):87-92.
[40] Hemingway CJ, Malhotra S, Almeida M, Azadian B, Yentis SM. The effect of alcohol swabs and filter straws on reducing contamination of glass ampoules used for neuroaxial injections. Anaesthesia. 2007; 62(3):286-8.
[41] Stehbens WE, Florey HW. The Behaviour of Intravenously Injected Particles Observed in Chambers in Rabbits'ears. Q J Exp Physiol Cogn Med Sci. 1960; 45(3):252-64.
[42] Lockhart JD. The medical significance of particulate matter in large volume parenteral solutions. In: National Symposium Proceedings. Safety of large volume parenteral solutions. 1966. p. 28. FDA.
[43] Garvan JM, Gunner BW. The harmful effects of particles in intravenous fluids. Med J Aust. 1964; 2(1):1-6.
[44] Michaels L, Poole RW. Injection granuloma of the buttock. Can Med Assoc J. 1970; 102(6):626.
[45] Belanger-Annable MC. Long-acting neuroleptics: technique for intramuscular injection. Can Nurse. 1985; 81(8):41-3.
[46] Hay J. Complications at site of injection of depot neuroleptics. BMJ. 1995; 311(7002):421.
[47] Brewer JH, Dunning JF. An in vitro and in vivo study of glass particles in ampules. J Am Pharm Assoc (Sci Ed). 1947; 36(10):289-93.
[48] Yorioka K, Oie S, Kamiya A. Comparison of particulate contamination in glass and plastic ampoules of glycyrrhizin injections after ampoule cutting. J Food Drug Anal. 2009; 17(3):3.
[49] Fry L. Glass micro-particulate contamination of intravenous drugs—should we be using filter needles? Aust Med Stud J. 2015; 6(1).
[50] Zabir AF, Choy CY, Rushdan R. Glass particle contamination of parenteral preparations of intravenous drugs in anaesthetic practice. S Afr J Anaesth Analg. 2008; 14(3):17-9.
[51] United States Pharmacopeial Convention. United States Pharmacopeia and National Formulary (USP 35–NF 30). Rockville (MD): United States Pharmacopeial Convention; 2012.
[52] Unahalekhaka A, Nuthong P, Geater A. Glass particles contamination in single dose ampoules: patient safety concern. Am J Infect Control. 2009; 37(5):E109-E110.
[53] Chiannilkulchai N, Kejkornkaew S. Safety concerns with glass particle contamination: improving the standard guidelines for preparing medication injections. Int J Qual Health Care. 2021; 33(2):mzab091.
[54] Craven RF, Hirnle CJ. Fundamentals of Nursing. 6th ed. Wolters Kluwer/Lippincott Williams & Wilkins; 2009.
[55] Timmons CL, Liu CY, Merkle S. Particulate generation mechanisms during bulk filling and mitigation via new glass vial. PDA J Pharm Sci Technol. 2017; 71(5):379-92.
[56] Bukofzer S, Ayres J, Chavez A, Devera M, Miller J, Ross D, et al. Industry perspective on the medical risk of visible particles in injectable drug products. PDA J Pharm Sci Technol. 2015; 69(1):123-39.
[57] Langille SE. Particulate matter in injectable drug products. PDA J Pharm Sci Technol. 2013; 67(3):186-200.
[58] Jack T, Brent BE, Boehne M, Müller M, Sewald K, Braun A, et al. Analysis of particulate contaminations of infusion solutions in a pediatric intensive care unit. Intensive Care Med. 2010; 36(4):707–711.
[59] Puntis JW, Wilkins KM, Ball PA, Rushton DI, Booth IW. Hazards of parenteral treatment: do particles count?. Arch Dis Child. 1992; 67(12):1475-7.
[60] Turco SJ, Davis NM. Detrimental effects of particulate matter on the pulmonary circulation. Jama. 1971; 217(1):81-2.
[61] Perez M, Décaudin B, Abou Chahla W, Nelken B, Barthelemy C, Lebuffe G, et al. In vitro analysis of overall particulate contamination exposure during multidrug IV therapy: impact of infusion sets. Pediatr Blood Cancer. 2015; 62(6):1042-7.
[62] Lofthus RM, Srebnik HH. The Physical Dimensions of the Human Neonatal Cardiovascular System. J Biomech Eng. 1987; 109(4):336–339.
[63] Heyman S. Toxicity and safety factors associated with lung perfusion studies with radiolabeled particles. J Nucl Med. 1979; 20(10):1098-9.
[64] Kienle PC, McElhiney LF, Kastango ES, Murdaugh LB, McCollum D, Power LA. ASHP guidelines on compounding sterile preparations. Am J Health Syst Pharm. 2014; 71(2):145–66.
[65] Yorioka K, Oie S, Oomaki M, Imamura A, Kamiya A. Particulate and microbial contamination in in-use admixed intravenous infusions. Biol Pharm Bull. 2006; 29(11):2321–3.
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How to Cite
1.
Mojarradi M, Kazemian K, Ghanbarzamani A, Ghaffari S, Shiehmorteza M. Examination of Glass Particulate Contamination after Ampoule Breakage. Arch Anesth & Crit Care. 2026;.
