Penilaian Risiko Kontaminasi Silang pada Area Produksi pada Salah Satu Industri Farmasi di DKI Jakarta

Christina Damayanti, Aliya Nur Hasanah

Sari

Kontaminasi silang dapat mempengaruhi mutu dan keamanan produk yang diproduksi oleh industri farmasi. Metode FMEA (Failure Modes and Effects Analysis) merupakan metode yang dapat digunakan untuk menilai risiko terjadinya kontaminasi silang. Penilaian risiko ini dilakukan dengan tahapan identifikasi risiko, analisis risiko, dan evaluasi risiko yang menggunakan pengkategorian berdasarkan Risk Priority Number (RPN). Berdasarkan hal tersebut, dilakukan penelitian berupa penilaian risiko kontaminasi silang pada area produksi pada salah satu industri farmasi di DKI Jakarta. Penelitian ini menunjukkan 38 risiko dengan kategori berdasarkan RPN yaitu rendah, sedang, tinggi, dan sangat tinggi dari keseluruhan proses produksi. Nilai RPN terendah sebesar ≤30 dan tertinggi sebesar ≥150. Berdasarkan nilai tersebut, didapatkan risiko dengan nilai RPN 30-60 (sedang), 75-100 (tinggi), dan lebih dari 150 (sangat tinggi) yang menjadi prioritas untuk menentukan tindakan pengendalian terhadap risiko yang telah teridentifikasi. Oleh karena itu, industri farmasi tersebut dapat segera menentukan dan melaksanakan tindakan pengendalian untuk mengurangi risiko keberulangan kontaminasi silang, seperti teknik pembersihan yang dimodifikasi serta pembungkusan peralatan kotor dan peralatan bersih yang tidak dilakukan. Tindakan pengendalian dapat dilakukan dengan pelatihan personil, perbaikan SOP, serta peningkatan fasilitas pembersihan sehingga mutu produk yang diproduksi tetap terjaga.

Kata Kunci

Industri Farmasi, Kontaminasi Silang, Penilaian Risiko

Teks Lengkap:

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Referensi

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DOI: https://doi.org/10.24198/mfarmasetika.v8i5.46906

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