Microbiological detection of plastic packaging con

2022-08-09
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Microbial detection of plastic packaging containers commonly used in hospital preparations

[Abstract] Objective To investigate the microbial contamination of plastic packaging materials commonly used in hospital preparations. Methods microbial limit test was used. Results all plastic packaging materials inspected were contaminated. Conclusion manufacturers should produce according to legal standards, and change large packaging into small and medium packaging, so as to avoid pollution caused by repeated use of preparations in medical units

key words: plastic container microbial pollution

the quality of drug packaging materials can directly affect the quality of drugs. Therefore, the packaging materials are very important for the pollution and protection of drugs. When the packaging materials themselves are polluted, it can bring pollution to the packaged drugs, affect the quality of drugs, and in serious cases, it can bring harm to patients. Drugs infected with bacteria can directly lead to infection of patients, drug-induced diseases, and even death. The national regulations on the administration of drug packaging point out that the packaging materials and containers that directly contact drugs must meet the pharmaceutical requirements and meet the standards to ensure poor installation accuracy, human health and safety [1]. In this paper, the pollution degree of five kinds of packaging containers commonly used in hospitals, such as ophthalmic, oral and external, was tested in order to provide basis for the quality of hospital preparations

1 instruments and reagents

1.1 instrument jht-ds purification workbench (Shandong Jinan air purification and disinfection equipment factory); HHS electric constant temperature water bath pot (Beijing Chang'an scientific instrument factory); Pyx-dhs waterproof electric constant temperature incubator (Shandong Weifang Medical Equipment Factory); Jy-1goa mold incubator (Shanghai Kangle Photoelectric Instrument Factory); Ym1190mm Petri dish (Shaanxi Qinchuan glassware factory)

1.2 reagent nutrient agar medium (batch No. 010402); Tiger red agar medium (batch number); Bile salt lactose medium (batch number); Nutritious broth (batch No. 000124); Cetyltrimethylammonium agar medium (batch No. 010117); Egg yolk sodium chloride agar basic medium (batch No. 001129); They are all produced by Beijing Sanyao technology development company and monitored by China Institute for the control of pharmaceutical and biological products. Escherichia coli 44102; Pseudomonas aeruginosa 10104; Staphylococcus aureus 26003; All are provided by Tai'an Institute for drug control. 0.9% sodium chloride injection (batch number, Rizhao ocean pharmaceutical factory of Shandong crystallization group)

plastic ophthalmic bottle, specification 10ml, 10000 pieces as a packaging unit; Plastic bottle for oral administration, 200ml in size, 500 for an outer packaging unit; Ointment box, specification 30g, 1000 pieces for a packaging unit (all produced by a plastic factory in Hejian)

2 experimental methods and results

2.1 methods microbiological examination adopts the microbiological limit examination method in Chinese Pharmacopoeia (2000 edition, Part II). The pipette used in the experiment and the utensils used for dilution were sterilized by dry heat at 160 ℃ for 2h and the culture medium at 121 ℃ for 15min

2.1.1 sampling method: random sampling from the original packaging of newly purchased plastic bottles, a: 11 eye drops; B: Oral medicine bottle; C: Mouthwash bottle; D: Unpacked oral medicine bottles; E: Take 5 ointment boxes respectively and put them in sterile containers to avoid secondary pollution

2.1.2 the preparation of the test solution is based on the dosage of the preparation variety, which is respectively filled with 0.9% normal saline, 8ml eye drops, 200ml oral medicine bottle and 30ml ointment box. Combine the liquid in each bottle into a sterile container, and then dilute it at 1:10 -1, 1:, 1:10 -3 respectively to obtain the test solution

2.1.2 plate colony count take 1ml of the test solution diluted for three consecutive levels (10 times) respectively, place it in a 90mm diameter plate, and then inject about 45 ℃ nutrient agar respectively; Tiger red agar medium is about 15ml, and two plates are made for each dilution stage. Mix well, put it in the incubator and culture upside down after solidification

2.2 results count the bacterial colony at 24 ~ 48h points, whichever is 48h. Count the colony number of mold and yeast at 48 ~ 72h points, whichever is 72h. Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, etc. were all tested according to the microbial limit method in the Chinese Pharmacopoeia (2000 applicable materials: Metallic and non-metallic materials, etc.) and the results were not detected. See Table 1. Table 1 bacterial culture results of each sample - note: I and II are the number of Petri dishes

3 discussion

the experimental results in this paper show that all kinds of products have varying degrees of pollution, of which C and D are the most serious; The experimental results also show that the degree of pollution of packaging materials depends on the production environment of the manufacturer and the storage conditions of the user

it is suggested that manufacturers should strictly enforce production standards, improve the production environment, and change the large packaging to small and medium-sized packaging suitable for the production of hospital preparations at all levels. The user unit shall clean, disinfect or sterilize the required containers, medicine bottles, bottle caps, etc. with appropriate methods in advance. The cleaned containers shall be provided with measures to prevent re pollution, so as to prevent the packaging containers from polluting the preparation and ensure the quality of the preparation

Xiao Jianhua, Guo Fengguang, sun Zhaorong, Wu Xia, Ming Shi, GUI Yun

Chinese Journal of practical medicine

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