ITP730 Faktor-Faktor Kritis pada Proses Sterilisasi dengan Retort (Form FDA 2541 dan FDA 2541a)

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1 ITP730 Faktor-Faktor Kritis pada Proses Sterilisasi dengan Retort (Form FDA 2541 dan FDA 2541a), PhD Southeast Asian Food & Agricultural Science & Technology (SEAFAST) Center, Bogor Agricultural University, BOGOR, Indonesia Department of Food Science & Technology, Bogor Agricultural University, BOGOR, Indonesia Member of Institute for Thermal Process Specialist (IFTPS)-USA PERHITUNGAN KECUKUPAN PROSES STERILISASI - Contoh Teixera, Thermal Process Calculation. Handbook of Food Eng.. 1

2 KENAPA FAKTOR KRITIS? Harus dilakukan upaya sistematis untuk (i) membuat, (ii) memverifikasi dan (iii) mendokumenkan bahwa : semua kondisi produk dan data pindah panas yang digunakan dalam menyusun SOP (scheduled process) tetap dipelihara sebagai kondisi proses yang rutin dilakukan dengan segala variasinya.. 2

3 APA SAJA FAKTOR KRITIS?. setiap sifat, karakteristik, kondisi, aspek, variasi atau prosedur atau parameter lain yang mungkin mempengaruhi kecukupan (panas) yang diberikan oleh proses standar (atau mempengaruhi capaian tingkat sterilisasi komersial) yang telah ditetapkan ( any property, characteristic, condition, aspect, variation or procedure or other parameter, of which affects the adequacy of the scheduled process and the attainment commercial sterility ) FDA (21CFR 113.3(f) and USDA FSIS 9 CFR and LACF Hybrid Definition-D.Park IFTPS 2007 APA SAJA FAKTOR KRITIS?. 3

4 APA SAJA FAKTOR KRITIS? APA SAJA FAKTOR KRITIS? FORM

5 FORM 2541 Initial registration ti baru; belum pernah mendapatkan FCE# Relocation masukkan FCE# yang masih dimiliki (current) dan isi form 2541 untuk mendapatkan FCE# baru Change registration information perubahan nama perusahaan, perubahan alamat, perumbahan pemilik, dll FORM 2541 When FDA has reviewed your submission, they will send you a copy of this submission with your FCE number listed in the proper location. 5

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8 FORM 2541A. 8

9 Separate filings required for: Each product, form or style, receiving a different process, or having different critical factors Each processing method even if the scheduled process (time, temperature) is the same. 9

10 Form 2541a Section A. Product Section B. Processing Method Section C. Critical Factors Section D. Scheduled Process A. PRODUCT. 10

11 B. PROCESSING METHODS. 11

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15 C. CRITICAL FACTORS C. CRITICAL FACTORS. 15

16 C. CRITICAL FACTORS C. CRITICAL FACTORS. 16

17 C. CRITICAL FACTORS D. SCHEDULED PROCESS. 17

18 D. SCHEDULED PROCESS - Container dimensions - Capacity units D. SCHEDULED PROCESS - Container dimensions - Capacity units. 18

19 D. SCHEDULED PROCESS - Container dimensions - Capacity units D. SCHEDULED PROCESS - Container dimensions - Capacity units. 19

20 D. SCHEDULED PROCESS - Container dimensions - Capacity units D. SCHEDULED PROCESS - Container dimensions - Capacity units. 20

21 D. SCHEDULED PROCESS - Container dimensions - Capacity units D. SCHEDULED PROCESS - Container dimensions - Capacity units. 21

22 D. SCHEDULED PROCESS - Container dimensions - Capacity units D. SCHEDULED PROCESS - Container dimensions - Capacity units. 22

23 D. SCHEDULED PROCESS - Container dimensions - Capacity units D. SCHEDULED PROCESS - Scheduled Process. 23

24 D. SCHEDULED PROCESS - Other Critical Factors D. SCHEDULED PROCESS - Comments, Etc Terimakasih. 24