Penyusunan Rancangan Pedoman Validasi Proses Dry Mixing pada Produk Pangan Olahan Kebutuhan Gizi Khusus MPASI.

Abstract

Proses pencampuran merupakan tahap penting dalam produksi Pangan Olahan Keperluan Gizi Khusus (PKGK) berbentuk bubuk, salah satunya Makanan Pendamping Air Susu Ibu (MPASI). Produk PKGK memiliki risiko tinggi sehingga memerlukan pengawasan ketat dan validasi proses untuk menjamin keseragaman campuran dan konsistensi mutu produk. Namun, hingga saat ini belum tersedia pedoman yang secara khusus mengatur validasi proses mixing pada industri PKGK. Penelitian ini bertujuan memperkaya kajian teknis proses dry mixing dan menyusun rancangan pedoman validasi proses mixing sebagai panduan bagi pelaku usaha. Penelitian ini menggunakan metode studi literatur, evaluasi laporan validasi mixing dari industri PKGK yang telah memiliki Izin Produksi Program Manajemen Risiko, penyebaran kuesioner, dan penyusunan rancangan pedoman. Hasil evaluasi terhadap 11 laporan validasi menunjukkan tingkat kelengkapan laporan berkisar antara 8–100%. Hasil kuesioner terhadap 29 industri (tingkat respon 74,4%) menunjukkan bahwa 79% industri menggunakan proses dry blend dan 69% menggunakan convective mixer. Dari 29 industri, empat industri memproduksi MPASI dan seluruhnya merupakan industri skala besar. Koefisien variasi dan Persamaan Horwitz merupakan metode yang paling banyak digunakan untuk olah data hasil uji homogenitas, serta 79% responden menyatakan membutuhkan pedoman resmi BPOM. Penelitian ini menghasilkan rancangan pedoman validasi proses mixing yang terdiri atas 10 bab, yaitu definisi, kompetensi operator mixer, jenis mixer, pohon keputusan penentuan marker, penentuan pengambilan sampel, alat pengambilan sampel, pengaturan operasi pencampuran, metode analisis, pengolahan data, dan tindak lanjut.

Mixing is a critical stage in the production of powdered Foods for Special Dietary Uses (FSDU), including Complementary Foods for Infants and Young Children or MPASI. FSDU products are considered high-risk products that require strict quality control and process validation to ensure blend uniformity and consistent product quality. However, no specific guideline is currently available for the validation of mixing processes in the FSDU industry. This study aimed to strengthen the technical basis of dry mixing processes and develop a mixing process validation guideline for industry implementation. The study employed a literature review, evaluation of mixing validation reports from FSDU manufacturers holding a Risk Management Program Production License, a questionnaire survey, and guideline development. The evaluation of 11 validation reports showed that report completeness ranged from 8–100%. The questionnaire results from 29 manufacturers (74.4% response rate) indicated that 79% used dry blending and 69% used convective mixers. Among the respondents, four manufacturers produced complementary infant foods, all of which were large-scale manufacturers. The coefficient of variation and the Horwitz equation were the most commonly used methods for processing homogeneity test data, and 79% of respondents expressed the need for an official BPOM guideline. This study produced a mixing process validation guideline consisting of ten chapters: definitions, mixer operator competency, mixer types, a marker selection decision tree, sampling determination, sampling equipment, mixing operation control, analytical methods, data processing, and corrective actions.