DESIGNING AND QUALITY ASPECTS OF ASEPTIC PROCESS SIMULATION
DOI:
https://doi.org/10.22159/ijap.2020v12i4.37410Keywords:
Aseptic Process Simulation, Validation, Media, Interventions, Gowning procedureAbstract
Aseptic process simulation is a crucial validation technique carried out before a new product or aseptic process is introduced in the facility and also to prove on regular intervals that the existing manufacturing operations are carried out in a state of aseptic conditions. Aseptic process simulation involves conducting aseptic production using a sterile growth medium instead of actual drug solution and excipients. The processes involved in aseptic validation include the identification of process mechanisms, variables and control methods and that also include product, component, and sterilization of equipment, sanitary facilities, environmental checks and staff training on gowning procedure. This review addresses the nature of the study involved in aseptic process simulation, speed and number of runs, runtime, the atmospheric conditions, line speed, the media used, incubating and analyzing media-filled units, data interpretation, worst-case parameters, interventions, case study on interventions and the regulatory aspects concerned with the simulation.
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References
Eurofins Scientific. Media Fill Studies. Available from: https://www.eurofins.com.au/biopharma-services/testing-solutions/sterile-products-testing/media-fill-studies/ [Last accessed 22 Dec 2019]
Kevin L Williams. Microbial contamination control in parenteral manufacturing. Taylor and Francis e-Library; 2005. p. 140.
Dgra de. Basic requirements for aseptic manufacturing of sterile medicinal products. Available from: https://dgra.de/media/pdf/studium/masterthesis/master_greger_g.pdf [Last accessed on 01 Feb 2020]
Devaraj B, Kali A, Charles MVP, Srinivasaiah Seethe K. Modified biphasic media for blood culture. Asian J Pharm Clin Res 2016;9:3
Diniatik, Sundhani E, Taufiq Nugroho M, Nur Hikmah E, Wahyuningrum R, Suparman. Antifungal and antibacterial activities of juice and ethanolic extracts of garcinia mangostana l. Leaves. Asian J Pharm Clin Res 2017;12:7
Silva B, TV Araujo, P Vasconcelos, H De Paula, N Nogueira, C Lira, et al. Gamma radiation as a method for sterilization of all-in-one admixtures bags for clinical use: a study of stability. Int J Pharm Pharm Sci 2015;7:129-35
Rubashvili I, Karukhnishvili N, Loria K, Dvali N. Cleaning validation for estimation of active ingredients’ residues of vicazid uncoated tablets (pyrantel 100 mg/mebendazole 150 mg) on surfaces of pharmaceutical manufacturing equipment using swab sampling and HPLC method. Int J Pharm Pharm Sci 2015;7:6
Deshmukh A. Aseptic process simulation: an assessment of aseptic processing capability. World J Pharm Res 2018;7:609-26.
Fda.gov. Guidance for industry sterile drug products produced by aseptic processing current good manufacturing practice; 2004. Available from: https://www.fda.gov/media/71026/download [Last accessed 29 Nov 2019]
Who.int. WHO good manufacturing practices for sterile pharmaceutical products; 2011. Available from: https://www.who.int/medicines/areas/quality_safety/quality _assurance/GMPSterilePharmaceuticalProductsTRS961Annex6.pdf [Last accessed on 17 Jan 2020]
Cleanroomtechnology.com. Managing aseptic gowning within classified environments. Available from: https://www.cleanroomtechnology.com/technical/article_page/Managing_aseptic_gowning_within_classified_environments/107339. [Last accessed on 21 Jan 2020]
Pharmaceuticalonline.com. How to Establish an Aseptic Gowning Qualification Program. Available from: https://www.pharmaceuticalonline.com/doc/how-to-establish-an-aseptic-gowning-qualification-program-0001 [Last accessed on 14 Feb 2020]
Fda.gov. Pharmaceutical microbiology manual; 2014. Available from: https://www.fda.gov/files/about%20fda/published/ Pharmaceutical-microbiology-manual.pdf [Last accessed on 09 Feb 2020].
Dcvmn.org. Aseptic processing practices and process validation of aseptic operators. Available from: https://www.dcvmn.org/IMG/pdf/cbe_ 107_aseptic_ processing_v1_dcvmn_beijing.pdf [Last accessed on 19 Dec 2019]
Kanchan C, Sangeeta D, Balasaheb G. A comparative survey of knowledge of antiseptic and disinfectant use and effect of intervention on medical and surgical staff nurses in a tertiary care hospital. Asian J Pharm Clin Res 2018;11:1
Picscheme.org. Pic/s guide to good practices for the preparation of medicinal products in healthcare establishments; 2014. Available from: https://www.picscheme.org/layout/document.php [Last accessed on 12 Dec 2019]
Mahdiani H, Doroud D, Shahali M, Pouyan N, Brufar F, Rahimi A, et al. A practical risk-based approach to assess vial’s dimensions deviations effect on the aseptic filling processing, according to ich q9 guideline. Int J Pharm Pharm Sci 2014;6:9
Igor Gorsky, Harold Baseman. Principles of parenteral solution validation. 1st ed. United States; 2014.
Jpdb.nihs.go.jp. Japanese Pharmacopoeia. 14 ed.; 2001. Available from: http://jpdb.nihs.go.jp/jp14e/14data/Medial_Fill_Test.pdf [Last accessed on 24 Nov 2019]
Pmda.go.jp. Guidance on the manufacture of sterile pharmaceutical products by aseptic processing; 2006. Available from: https://www.pmda.go.jp/files/000153543.pdf [Last accessed 06 Dec 2019]
Picscheme.org. Validation of aseptic processes; 2011. Available from: https://pi007_6recommendationonasepticprocesses.pdf [Last Accessed on 16 Dec 2019]
Express I. Express pharma. Vol. 11; 2016. Available from: https://issuu.com/indianexpressgroup/docs/ep-20160131pages [Last Accessed on 16 Dec 2019]
Gmpua.com. Good manufacturing practice. Available from: https://gmpua.com/index_en.php [Last accessed on 25 Feb 2020].
Pdfs.semanticscholar.org. Available from: https://pdfs.semanticscholar.org/f9e4/4891aa9314a30fcf05b1c19e1ca7c55054c0.pdf [Last accessed on 05 Mar 2020]
Kolhe P, Shah M, Rathore N, York S. Sterile product development-formulation, process, quality and regulatory considerations | parag kolhe | springer. Springer. com.bfsioa.org. Validation of aseptic fill process. Available from: https://www.bfsioa.org/media/12ad469f-23d9-4511-a5ab-a8adec9b8071/7mVnzw/2018%20Kunming/Validation%20of%20aseptic%20fill%20process.pdf [Last accessed 08 Feb 2020]
Bfsioa.org. Validation of aseptic fill process. Available from: https://www.bfsioa.org/media/12ad469f-23d9-4511-a5ab-a8adec9b8071/7mVnzw/2018%20Kunming/Validation%20of%20aseptic%20fill%20process.pdf [Last accessed on 08 Feb 2020]
Bio-equip.cn. Soyabean casein digest agar with lecithin and polysorbate 80, 90 mm (ASCDA002), specification, price, image-Bio-Equip in China. Available from: https://bio-equip.cn/enshow1equip.aspequipid=71194 [Last accessed on 13 Feb 2020]
Pharmasopcorner.net. Available from: https://www.pharmasopcorner.net/2019/09/soyabean-casein-digest-agar.html [Last accessed on 04 Feb 2020]
Choudhary A. Media fill validation-SVP. Pharmaguideline.com. Available from: https://www.pharmaguideline.com/2011/04/media-fill-validation-svp.html [Last accessed on 18 Jan 2020]
Cleanroomtechnology.com. Media fill simulations; 2014. Available from: https://www.cleanroomtechnology.com/news/article_page/Media_fill_simulations/103050 [Last accessed on 02 Mar 2020]
Sandle T. Designing aseptic process simulations: the time and container number conundrum. Ivtnetwork.com; 2016.
Biotechnologysolutions.com. Phenol red dextrose (PRD)–BTS–biotechnology Solutions. Available from: https://biotechnologysolutions.com/phenol-red-dextrose-prd/ [Last accessed on 03 Mar 2020]
J Agalloco. Managing aseptic interventions. J Pharm Technol 2005. p. 56-66.
Richard L. Friedman. Aseptic processing contamination case studies and the pharmaceutical quality system. PDA JPST 2005;59:118-26.
