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1Purwiyatno Hariyadi …. [email protected]
ITP730Faktor-Faktor Kritis pada
S l d Proses Sterilisasi dengan Retort(Form FDA 2541 dan FDA 2541a)
Purwiyatno Hariyadi, PhD• Southeast Asian Food & Agricultural Science & Technology
(SEAFAST) Center, Bogor Agricultural University, BOGOR,
Purwiyatno [email protected]
( ) , g g y, ,Indonesia
• Department of Food Science & Technology, Bogor Agricultural University, BOGOR, Indonesia
• Member of Institute for Thermal Process Specialist (IFTPS)-USA
Teixera, 1992. Thermal Process Calculation. Handbook of Food Eng.
PERHITUNGAN KECUKUPAN PROSES STERILISASI- Contoh
Purwiyatno [email protected]
2Purwiyatno Hariyadi …. [email protected]
Purwiyatno [email protected]
KENAPA FAKTOR KRITIS?
Harus dilakukan upaya sistematis untuk(i) membuat(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
Purwiyatno [email protected]
yang rutin dilakukan dengan segala variasinya.
3Purwiyatno Hariyadi …. [email protected]
“…. setiap sifat, karakteristik, kondisi, aspek, variasi atau prosedur atau parameter lain yang mungkin mempengaruhi kecukupan (panas) yang diberikan oleh
APA SAJA FAKTOR KRITIS?
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”)
Purwiyatno [email protected]
FDA (21CFR 113.3(f) and USDA FSIS 9 CFR 318.303 and 381.303 LACF “Hybrid”Definition-D.Park IFTPS 2007
APA SAJA FAKTOR KRITIS?
Purwiyatno [email protected]
4Purwiyatno Hariyadi …. [email protected]
APA SAJA FAKTOR KRITIS?
Purwiyatno [email protected]
APA SAJA FAKTOR KRITIS?
Purwiyatno [email protected]
FORM 2541
5Purwiyatno Hariyadi …. [email protected]
FORM 2541
I iti l i t ti b b l h d tk FCE#
Purwiyatno [email protected]
• Initial registration 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
Purwiyatno [email protected]
When FDA has reviewed your submission, they will send you a copy of this submission with your FCE number listed in the proper location
8Purwiyatno Hariyadi …. [email protected]
FORM 2541A
Purwiyatno [email protected]
Purwiyatno [email protected]
9Purwiyatno Hariyadi …. [email protected]
Purwiyatno [email protected]
Separate filings required for:
• Each product form or style receiving aEach product, form or style, receiving a different process, or having different critical factors
• Each processing method even if the scheduled process (time, temperature) is
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( )the same
10Purwiyatno Hariyadi …. [email protected]
Form 2541a
Section A. ProductSection B. Processing MethodSection C. Critical Factors
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Section D. Scheduled Process
A. PRODUCT
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11Purwiyatno Hariyadi …. [email protected]
Purwiyatno [email protected]
B. PROCESSING METHODS
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12Purwiyatno Hariyadi …. [email protected]
Purwiyatno [email protected]
Purwiyatno [email protected]
13Purwiyatno Hariyadi …. [email protected]
Purwiyatno [email protected]
Purwiyatno [email protected]
14Purwiyatno Hariyadi …. [email protected]
Purwiyatno [email protected]
Purwiyatno [email protected]
15Purwiyatno Hariyadi …. [email protected]
C. CRITICAL FACTORS
Purwiyatno [email protected]
C. CRITICAL FACTORS
Purwiyatno [email protected]
16Purwiyatno Hariyadi …. [email protected]
C. CRITICAL FACTORS
Purwiyatno [email protected]
C. CRITICAL FACTORS
Purwiyatno [email protected]
17Purwiyatno Hariyadi …. [email protected]
C. CRITICAL FACTORS
Purwiyatno [email protected]
D. SCHEDULED PROCESS
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18Purwiyatno Hariyadi …. [email protected]
D. SCHEDULED PROCESS
- Container dimensions- Capacity units
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D. SCHEDULED PROCESS- Container dimensions- Capacity units
Purwiyatno [email protected]
19Purwiyatno Hariyadi …. [email protected]
D. SCHEDULED PROCESS- Container dimensions- Capacity units
Purwiyatno [email protected]
D. SCHEDULED PROCESS- Container dimensions- Capacity units
Purwiyatno [email protected]
20Purwiyatno Hariyadi …. [email protected]
D. SCHEDULED PROCESS- Container dimensions- Capacity units
Purwiyatno [email protected]
D. SCHEDULED PROCESS- Container dimensions- Capacity units
Purwiyatno [email protected]
21Purwiyatno Hariyadi …. [email protected]
D. SCHEDULED PROCESS- Container dimensions- Capacity units
Purwiyatno [email protected]
D. SCHEDULED PROCESS- Container dimensions- Capacity units
Purwiyatno [email protected]
22Purwiyatno Hariyadi …. [email protected]
D. SCHEDULED PROCESS- Container dimensions- Capacity units
Purwiyatno [email protected]
D. SCHEDULED PROCESS- Container dimensions- Capacity units
Purwiyatno [email protected]
23Purwiyatno Hariyadi …. [email protected]
D. SCHEDULED PROCESS- Container dimensions- Capacity units
Purwiyatno [email protected]
D. SCHEDULED PROCESS- Scheduled Process
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24Purwiyatno Hariyadi …. [email protected]
D. SCHEDULED PROCESS- Other Critical Factors
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D. SCHEDULED PROCESS- Comments, Etc
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