Email this article Improvement of quality control of water for pharmaceutical purposes obtained in the field
- Authors: Enikeeva R.A.1, Miroshnichenko Y.V.1, Alekseychuk E.Y.1
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Affiliations:
- Military Medical Academy
- Issue: Vol 42, No 1 (2023)
- Pages: 37-42
- Section: Original articles
- URL: https://journals.eco-vector.com/RMMArep/article/view/306861
- DOI: https://doi.org/10.17816/rmmar306861
- ID: 306861
Cite item
Abstract
The important component of military healthcare activities is development of new models of complete scheduled medical supplies, including those intended for the produce and quality control of medicines in military pharmacies and in military field hospitals. The article presents data of the creation of a self-sufficient set that allows to monitor the quality of purified water and water for injection in the field during a specified period. Now the available complete scheduled medical supplies do not contain materials and items for water quality control.
The goal of the article was to substantiate the approaches to the creation of a set “Complete scheduled medical supplies for monitoring the quality of purified water and water for injection” (CQW), the selection of the nomenclature and the determination of the amount of materials and items necessary for its completion, also the assessment of patentability. The CQW is a set with regulated property in terms of composition and quantity, which are statically fixed in a plastic container and ready for use. There are advantages set indicated (self-sufficiency, portability, protection from the effects of external environmental conditions, etc.).
The authors of the article make a conclusion about the patentability of the product (application for invention N 2023101440). At the end of the article, the conclusion is formulated that the inclusion of the CQW in the composition of the complete scheduled medical supplies will improve the production activities of military pharmacies in the field, which will greatly contribute to improving the efficiency of medical care for the wounded and injured in military conflicts and extreme situations.
Full Text
BACKGROUND
Providing the Armed Forces of the Russian Federation with weapons, military and special machinery, and material and technical means created based on breakthrough research is considered an unconditional priority in achieving the goals of national security .1 In this regard, the development of new types of complete and standard equipment, including those intended for the manufacture and quality control of medicinal products (MPs) in pharmacies of medical evacuation chains, and military field hospitals, is an important component of the activities of military healthcare [1]. However, the sets of medical equipment used for this purpose, namely, military pharmacy kit, assistant pharmacy kit, and injection pharmacy kit, do not contain a sufficient range of materials and items for intra pharmaceutical quality control of MPs, including water for injection (WFI) and purified water (PW), which are the most important components of liquid sterile and nonsterile MPs [2, 3]. The quality indicators and methods for testing these types of water for pharmaceutical purposes are regulated by pharmacopoeial articles FS.2.2.0019.18 “Water for Injections”2 and FS.2.2.0020.18 “Purified Water”3 [4]. Moreover, the requirements of these pharmacopoeial articles fully apply to water for pharmaceutical purposes in the field. Accordingly, research on the development of a “Stacking kit for the quality control of PW and WFI” (hereinafter referred to as the WQC stacking kit [WQK]) is extremely relevant [5].
This study aimed to substantiate approaches to the formation of a WQK and the range and quantity of materials and items necessary for its completion and evaluate the patentability of the WQK.
MATERIALS AND METHODS
The research materials were legislative and regulatory legal acts of the Russian Federation, regulatory legal acts of federal executive authorities (including the State Pharmacopoeia of the Russian Federation, XIV edition), resources of information retrieval systems (including the Federal Institute of Industrial Property and State Public Scientific and Technical Library), and scientific publications in the field of manufacturing and quality control of MPs. During the study, systemic and problematic methodological approaches were used, which were implemented using content analysis, structural–functional methods, logical analysis, comparative and descriptive methods, and patent search techniques. A patent search was performed by subject and nominal algorithms, and by the search for patent analogs (prototypes).
To form the WQK, instruments and tools for laboratories, laboratory grassware, consumables, chemical reagents and indicators, books and forms of accounting and reporting, and a plastic storage container with dividers were used.
RESULTS AND DISCUSSION
Substantiation of approaches to the formation of the WQK
The quality control of pharmaceutical substances and excipients is an obligatory stage in the technological process of drug manufacturing. However, in the field, testing of pharmaceutical substances, excipients and manufactured drugs is associated with many risks. Moreover, the quality indicators and frequency of control of MPs manufactured in medical evacuation chain pharmacies and military field hospitals must comply with the established requirements4 [6, 7]. Thus, in PW and/or WFI, the absence of chloride ions, sulfate ions, calcium salts, and pH is monitored daily. Additionally, WFI is tested for the absence of reducing agents, ammonium salts, and carbon dioxide. PW and WFI are also quarterly subjected to complete qualitative and quantitative analyses. The results of the tests are recorded in the “Registration log of the results of the control of PW and WFI.”
In the field, the control of water quality indicators for pharmaceutical purposes should be performed as soon as possible and close to the technical means of its production (e.g., sterilization–distillation unit [SDP]). Moreover, the use of approaches and material and technical equipment provided for stationary conditions for this purpose is practically impossible [8].
As part of the military scientific support of development activity on the creation of a modern sterilization and distillation unit (SDP-4), designed to obtain PW and WFI in the field, research was performed on the initiative to create a self-sufficient set of laboratory equipment (devices, tools, utensils, etc.) and consumables (reagents, indicators, etc.) that can be used, during the established period, to control the physical and chemical indicators of the quality of PW and/or WFI obtained in the field, provisioned by pharmacopoeial articles FS.2.2.0019.18 (WFI) and FS.2.2.0020.18 (PW) [9].
Brief description of the WQK
The WQK represents a set of properly regulated in terms of composition and quantity (medical consumable items, apparatus, laboratory devices and tools, laboratory glassware, consumable materials and accessories, pharmacy consumable items, consumable sanitary and household property, chemical reagents and indicators, books and accounting and reporting forms for material assets, standard equipment, and containers), which ensures the implementation of all procedures to control the quality indicators of PW and WFI in accordance with the established requirements. All components of the WQK are statically fixed in a plastic opaque container for storage and transportation and are ready for use.
The set of analytical reagents included diluted nitric acid 16%, silver nitrate solution 2%, barium chloride solution 6.1%, diluted hydrochloric acid 7.3%, ammonium chloride ammoniac buffer solution pH = 10.0, Eriochrome black T indicator mixture, sodium edetate (Trilon B) 0.05 M, potassium permanganate 0.1 M, diluted sulfuric acid 16%, calcium hydroxide solution, Nessler’s reagent, and laboratory tools. In addition, the WQK included a universal reagent paper (pH = 0–14.0), brush for washing test tubes, log for recording the results of the PW and WFI tests (20 sheets), pencil, glass pencil (vitreograph), 100-mL shake flask without a ground joint, graduated centrifuge test tube, chemical test tubes 14 × 120 mm, laboratory glass spirit lamp with a cap, 50-mL chemical beaker with a spout, stand for 10 test tubes, and some other items.
The WQK is self-sufficient and easy to use and can be formed at a relatively low cost. It is designed for a senior pharmacist (pharmacist); according to the consumables, it is intended for 1 month of work (for 30–35 tests). A prototype of the WQK is presented in Fig. 1.
The approbation of the WQK was performed during preliminary and state tests of prototypes of SDP-4 sterilization and distillation unit in the Institute of Pharmacy of the Tyumen State Medical University of the Ministry of Health of Russia. Data convincingly indicate that with the use of WQC, the methods (techniques) provided for by the relevant pharmacopoeial articles, the established quality indicators of PW and/or WFI can be controlled within a month [10].
Providing the chains of medical evacuation, military field hospitals, and other medical units equipped with technical means for obtaining PW and/or WFI (e. g., water distillers or sterilization–distillation installations) with the WQK s is encouraged.
Evaluation of the WQK patentability
The results of a patent search established that the utility model Complete Field Laboratory for Chemical Analysis of Water and Soil Extracts water quality kit is the closest prototype of the WQK 5. Its fundamental difference from the proposed WQK is its purpose, as the field laboratory does not belong to the field of pharmacy and is not intended to assess the quality of drugs and/or excipients (in this case, PW and WFI). In addition, its disadvantages are the difficulty in conducting the necessary analyses in the field and the relatively high cost of components (e.g., due to the presence of devices for photocolorimetric analysis).
Based on this, the patentability of the WQK was established, which was the basis for the preparation and filing of an application for an invention (accepted under the number 2023101440)6.
Fig. 1. Stacking kit “Set for the analysis of purified water and water for injection in the field.”
CONCLUSION
In the course of the initiative scientific research, for the first time, a WQC kit was created to control the quality of PW and WFI in the field. The results of the patent search showed its novelty and patentability. The inclusion of the WQK in the composition of standard basic equipment will significantly improve the production activities of military pharmacies in the field, which will greatly contribute to improving the efficiency of providing medical care to the wounded and injured in military conflicts and extreme situations.
ADDITIONAL INFORMATION
Funding. The study had no external funding.
Conflict of interest. The authors declare no conflict of interest.
Ethical considerations. This article does not contain any studies involving humans and animals as subjects of study.
Author contributions. All authors made a significant contribution to the study and preparation of the article, read and approved the final version before its publication.
1 Order of the President of the Russian Federation of July 2, 2021 No. 400 “On the National Security Strategy of the Russian Federation.”
2 FS.2.2.0019.18. Water for Injections. State Pharmacopoeia of the Russian Federation, XIV, 3rd ed., Moscow (2018).
3 FS.2.2.0020.18. Purified Water. State Pharmacopoeia of the Russian Federation, XIV, 3rd ed., Moscow (2018).
4 Order of the Ministry of Health of the Russian Federation No. 751n dated October 26, 2015 “On Approval of the Rules for the Manufacture and Delivery of Medicinal Drugs by Pharmacy Organizations, Individual Entrepreneurs Licensed for Pharmaceutical Activities.”
5 A.G. Muravyov, B.V. Smolev, and A.N. Ustrova, RF patent for utility model No. 123777/ 27.07.2010 Bull. No. 21, Complete Field Laboratory for Chemical Analysis of Water and Soil Extracts WQK (variants).
6 A positive decision dated February 14, 2023 on application No. 2023101440 dated January 24, 2023 for the invention by Yu.V. Miroshnichenko, R.A. Enikeeva, E.Yu Alekseychuk “Stacking kit for control of the quality of purified water and water for injection in the field.”
About the authors
Rimma A. Enikeeva
Military Medical Academy
Email: rimmaspec@mail.ru
SPIN-code: 4917-6516
Scopus Author ID: 821707
M.D., Ph.D. (Pharmaceuticals), Assoc. Prof. of Military-medical supply and pharmacy Department
Russian Federation, Saint PetersburgYuriy V. Miroshnichenko
Military Medical Academy
Email: miryv61@gmail.com
SPIN-code: 9723-1148
Scopus Author ID: 820849
M.D., D.Sc. (Pharmaceuticals), Professor
Russian Federation, Saint PetersburgEkaterina Yu. Alekseychuk
Military Medical Academy
Author for correspondence.
Email: kati1882@mail.ru
ORCID iD: 0000-0001-9241-9519
SPIN-code: 8730-4623
Scopus Author ID: 1093458
Russian Federation, Saint Petersburg
References
- Miroshnichenko YuV, Ivchenko EV, Kononov VN, et al. Perspective directions of innovative development of pharmacy in military healthcare in Russia. Bulletin of the Russian Military Medical Academy. 2022;24(1):179–188. (In Russ.) doi: 10.17816/brmma101106
- Lopatin SA, Yudin AB, Volodin AS, Bokarev MA. Problematic issues and prospects for improving water quality control in the field. Military Medical Journal. 2022;343(4):45–52. (In Russ.) doi: 10.52424/00269050_2022_343_4_45
- Rodionov EO. Approaches to equipping military pharmacies in the field. Modern organization of drug supply. 2015;(2):66. (In Russ.)
- Ozderbieva DA, Mal’ceva EM. The comparative analysis of pharmacopoeia requirements to the purified water and water for injections. Actualscience. 2016;2(12):201–204. (In Russ.)
- Sobolenko AK, Prigorelov OG, Zlenko VE, et al. Mobile pharmaceutical complexes: realities and development prospects. In: Prikladnyye voprosy voyennoy meditsiny. Materials of the All-Russian interdepartmental scientific-practical conference. Saint Petersburg. 2021. P. 196–199. (In Russ.)
- Klimkina EA, Enikeeva RA, Zhidkova UU, Vatanskaya OA. Approaches to the production of medicines in the field. Modern organization of drug supply. 2021;8(1):61–62. (In Russ.)
- Rodionov EO, Saushkina AS, Klimkina EA. Production and quality control of medicines in the field. Russian Military Medical Academy Reports. 2020;39(S3–4):238–240. (In Russ.)
- Miroshnichenko YuV, Bunin SA, Kononov VN, Popov AA, Rodionov EO. Justification of modern approaches to classification of medical equipment sets. Military Medical Journal. 2016;337(3):22–29. (In Russ.) doi: 10.17816/RMMJ73551
- Miroshnichenko YuV, Enikeeva RA, Alekseychuk EYu. Comparative analysis of the tactical and technical characteristics of military equipment designed to obtain water for pharmaceutical purposes in the field. In: Kononov V.N., Golubenko R.A., eds. Aktual’nye voprosy razvitiya rossiyskoy farmatsii — Il’inskie chteniya. Materials of the XI annual interuniversity interregional scientific conference, St. Petersburg, December 09–10, 2021. Saint Petersburg: Voenno-medicinskaya akademiya imeni S.M. Kirova, Publishing House; 2022. P. 179–189. (In Russ.)
- Miroshnichenko YuV, Yakovlev SV, Kononov VN, et al. Implementation of modern approaches to testing organic equipment of the medical service of the armed forces. Military Medical Journal. 2018;339(4):49–54.
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