ASEPTIC PROCESS VALIDATION DESIGN AT XYZ PHARMA LTD

• Main Author: Sarano, Rionaldo
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/76326
• Institution: Institut Teknologi Bandung

One part of ensuring the quality of sterile products produced aseptically is validating the aseptic process (media fill) or also known as aseptic process simulation. Aseptic process validation is a process simulation test using growth media. The media used must pass the Growth Promotion Test (GPT) using 10-100 cfu of gram-positive, gram-negative microbes, anaerobic bacteria, molds, and yeast. This research was conducted in a pharmaceutical industry XYZ which produces sterile products aseptically. Validation of the aseptic process is carried out under normal production conditions and is documented in the batch record. The duration of the process simulates the longest normal batch production process including interventions that occur including routine and non-routine simulations that occur during the production process. The aseptic simulation test is carried out as closely as possible to the aseptic process in routine production, including all containers and equipment used and process parameters, number of personnel and activities including all critical steps in the manufacturing stage. In the aseptic process validation begins with determining the validation design, implementing the media fill and determining the disposition of the results according to predetermined acceptance criteria. Implementation of aseptic process validation starts from the weighing process, ampoule washing, mixing process to filling process. A risk study was carried out in selecting product markers in media fill and product A was selected with an ampoule size of 1 ml. During the media fill process, sampling and evaluation were carried out in each process. The results of this study showed that the validation of the aseptic process carried out in sterile production facilities in the XYZ Farma industry met the requirements, namely not a single cloudy ampoule was found.