KUALIFIKASI KINERJA ISOLATOR DI INDUSTRI FARMASI X

Putri Nur Azizah, Aliya Nur Hasanah

Abstrak


Abstrak

Kualifikasi merupakan proses dalam membutikan bahwa alat, fasilitas, dan sistem penunjang telah dipasang dengan benar, beroperasi sesuai desain yang telah ditetapkan dan memberikan hasil yang konsisten dalam menjaga kualitas produk sesuai spesifikasi yang telah ditentukan. Penelitian ini dilakukan untuk mengetahui hasil kualifikasi ulang yang dimulai dari kualifikasi kinerja pada sistem isolator. Kualifikasi ulang dilakukan untuk memastikan bahwa alat atau sistem memberikan hasil yang konsisten sesuai spesifikasi. Penelitian ini dilakukan dengan melakukan pemeriksaan parameter kritis secara langsung di industry farmasi PT X yang memproduksi obat kanker di Jakarta. Hasil pemeriksaan air velocity berada pada rentang 0,37-0,41 m/s. Hasil smoke test menunjukkan aliran udara laminar. Hasil pengukuran integrity testing filter memiliki efisiensi yang sangat tinggi yaitu 99,99%. Suhu dan kelembaban berturut-turut berada pada rentang 21,7-24,7oC dan 39,1-46,4%. Jumlah partikel udara ≥ 0.5 μm dan ≥ 5 μm masing-masing 79 dan 2 partikel. Hasil uji mikrobiologi metode air sampler, settle plate, dan contact plate tidak menunjukkan pertumbuhan mikroba. Berdasarkan hasil penelitian tersebut, sistem isolator dapat bekerja dengan baik karena semua parameter telah memenuhi syarat.

Kata kunci: isolator, kualifkasi kinerja, obat kanker

ABSTRACTQualification is a process of proving that tools, facilities, and supporting systems have been installed correctly, operate according to the established design and provide consistent results in maintaining product quality according to the specified specifications. This study was conducted to determine the results of re-qualification starting from performance qualification on the isolator system. Requalification is performed to ensure that the equipment or system delivers consistent results according to specifications. This study was conducted by directly examining critical parameters in the pharmaceutical industry of PT X which produces cancer drugs in Jakarta. The results of the air velocity examination were in the range of 0.37-0.41 m/s. The smoke test results showed laminar air flow. The results of the integrity testing filter measurement had a very high efficiency of 99.99%. Temperature and humidity were in the range of 21.7-24.7oC and 39.1-46.4%, respectively. The number of air particles ≥ 0.5 μm and ≥ 5 μm were 79 and 2 particles, respectively. The results of the microbiological tests using the air sampler, settle plate, and contact plate methods did not show microbial growth. Based on the research results, the isolator system can work well because all parameters have met the requirements.Keywords: isolator, performance qualification, cancer drug 



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DOI: https://doi.org/10.24198/farmaka.v22i3.60850

DOI (PDF): https://doi.org/10.24198/farmaka.v22i3.60850.g26032

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