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Penerapan Pengendalian Mutu pada Produk Rantai Dingin dalam Validasi Pengiriman Distribusi Obat
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Pedagang Besar Farmasi (PBF) bertanggung jawab menjaga mutu produk farmasi sesuai dengan ketentuan Cara Distribusi Obat yang Baik (CDOB). Salah satu hal penting yang diatur adalah pengawasan terhadap produk rantai dingin yang peka terhadap suhu. Pengendalian mutu harus dilakukan sejak tahap penerimaan, penyimpanan, hingga pendistribusian ke konsumen. Untuk menjamin kualitas produk selama proses pengiriman, dilakukan validasi pengiriman produk rantai dingin yang bertujuan memastikan bahwa produk tetap berada dalam rentang suhu yang ditetapkan demi keselamatan pasien. Pengujian ini menggunakan coolbox sebagai media pengiriman untuk menilai berapa lama suhu dapat dipertahankan serta menentukan waktu pengkondisian sebelum produk dipindahkan. Dalam pengujian digunakan empat ice pack, dan suhu dipantau selama 24 jam menggunakan thermo logger dengan interval pencatatan setiap 10 menit, kemudian data dianalisis menggunakan aplikasi Testo Comfort Software Basic 5.0. Hasil evaluasi menunjukkan bahwa coolbox dengan empat ice pack mampu menjaga suhu paling lama, yaitu hingga 18 jam ± 2,044.
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