Validation of cleaning procedures in the pharmaceutical laboratory of the Armed Forces National Health Direction
DOI:
https://doi.org/10.35954/SM2018.37.1.5Keywords:
Contamination; Air Pollutants, Occupational; Validation StudiesAbstract
The elaboration of pharmaceutical products implies a meticulous control of each stage of the process since the target public constitutes a vulnerable population. It is essential to ensure the cleanliness of the manufacturing equipment in order to avoid cross contamination. The cleaning of tablet manufacturing equipment was validated. The process was divided into wet granulation and direct compression, from the risk study the active ingredient Trimethoprim was selected in the product Sulfaprim or Sulfaprim strong for wet granulation, and the active Bromazepan in the product Bromazepan 6 DNSFFAA for direct compression. The cleaning procedure was applied. The surface limit of active principle was calculated adopting the Fourman and Mullen criterion. Sampling was performed by swabbing. The HPLC and UV analytical methods were validated to demonstrate that they are capable of recovering and determining traces of contaminants on the surface of the equipment. The used equipment was swabbed in 3 consecutive lots of each product. All of them showed values of the active principle lower than the allowed limit.
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(1) Ministerio de Salud Pública. Uruguay. Guía de Validación de Limpieza. 7 páginas. Disponible en: http://www.msp.gub.uy/sites/default/files/GUIA_DE_VALI-DACION_DE_LIMPIEZA.pdf [Consulta 15/07/2017].
(2) Fourman G, Mullen M. Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations. Pharm Tech 1993; 17(4):54.
(3) World Health Organization. Supplementary guidelines on good manufacturing practices: validation. Technical Report Series No.937, WHO 2006. 72 páginas. Disponible en: http://www.who.int/medicines/areas/quality_safety/quality_assurance/SupplementaryGMP-ValidationTRS937Annex4.pdf [Consulta 20/06/2017].
(4) ICH Harmonised Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2(R1). 17 páginas. Disponible en: https://www.ich.org/filead-min/Public_Web_Site/ICH_Products/Guidelines/Qua-lity/Q2_R1/Step4/Q2_R1__Guideline.pdf, ICH Guide-line Q2A. [Consulta 20/08/2017].
(5) Farmacopea de los Estados Unidos de América Formulario Nacional. USP 38-NF 33. 2015. Volumen 1. Capítulos Generales <1225>.Validación de proce-dimientos farmacopeicos p.1581- 1587.
(6) Estévez C, Quiroga F, Rojas J, Hernández H. Validación de una metodología analítica para la determinación de acetaminofén en procesos de limpieza. Rev Col Cienc Quim Farm 2003; 32(2):103-110.
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