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1 Purwiyatno Hariyadi …. [email protected] ITP730 Faktor-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 Hariyadi [email protected] 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 Hariyadi [email protected]

(Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

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Page 1: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

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]

Page 2: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

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.

Page 3: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

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]

Page 4: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

4Purwiyatno Hariyadi …. [email protected]

APA SAJA FAKTOR KRITIS?

Purwiyatno [email protected]

APA SAJA FAKTOR KRITIS?

Purwiyatno [email protected]

FORM 2541

Page 5: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

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

Page 6: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

6Purwiyatno Hariyadi …. [email protected]

Purwiyatno [email protected]

Purwiyatno [email protected]

Page 7: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

7Purwiyatno Hariyadi …. [email protected]

Purwiyatno [email protected]

Purwiyatno [email protected]

Page 8: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

8Purwiyatno Hariyadi …. [email protected]

FORM 2541A

Purwiyatno [email protected]

Purwiyatno [email protected]

Page 9: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

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

Purwiyatno [email protected]

( )the same

Page 10: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

10Purwiyatno Hariyadi …. [email protected]

Form 2541a

Section A. ProductSection B. Processing MethodSection C. Critical Factors

Purwiyatno [email protected]

Section D. Scheduled Process

A. PRODUCT

Purwiyatno [email protected]

Page 11: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

11Purwiyatno Hariyadi …. [email protected]

Purwiyatno [email protected]

B. PROCESSING METHODS

Purwiyatno [email protected]

Page 12: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

12Purwiyatno Hariyadi …. [email protected]

Purwiyatno [email protected]

Purwiyatno [email protected]

Page 13: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

13Purwiyatno Hariyadi …. [email protected]

Purwiyatno [email protected]

Purwiyatno [email protected]

Page 14: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

14Purwiyatno Hariyadi …. [email protected]

Purwiyatno [email protected]

Purwiyatno [email protected]

Page 15: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

15Purwiyatno Hariyadi …. [email protected]

C. CRITICAL FACTORS

Purwiyatno [email protected]

C. CRITICAL FACTORS

Purwiyatno [email protected]

Page 16: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

16Purwiyatno Hariyadi …. [email protected]

C. CRITICAL FACTORS

Purwiyatno [email protected]

C. CRITICAL FACTORS

Purwiyatno [email protected]

Page 17: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

17Purwiyatno Hariyadi …. [email protected]

C. CRITICAL FACTORS

Purwiyatno [email protected]

D. SCHEDULED PROCESS

Purwiyatno [email protected]

Page 18: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

18Purwiyatno Hariyadi …. [email protected]

D. SCHEDULED PROCESS

- Container dimensions- Capacity units

Purwiyatno [email protected]

D. SCHEDULED PROCESS- Container dimensions- Capacity units

Purwiyatno [email protected]

Page 19: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

19Purwiyatno Hariyadi …. [email protected]

D. SCHEDULED PROCESS- Container dimensions- Capacity units

Purwiyatno [email protected]

D. SCHEDULED PROCESS- Container dimensions- Capacity units

Purwiyatno [email protected]

Page 20: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

20Purwiyatno Hariyadi …. [email protected]

D. SCHEDULED PROCESS- Container dimensions- Capacity units

Purwiyatno [email protected]

D. SCHEDULED PROCESS- Container dimensions- Capacity units

Purwiyatno [email protected]

Page 21: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

21Purwiyatno Hariyadi …. [email protected]

D. SCHEDULED PROCESS- Container dimensions- Capacity units

Purwiyatno [email protected]

D. SCHEDULED PROCESS- Container dimensions- Capacity units

Purwiyatno [email protected]

Page 22: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

22Purwiyatno Hariyadi …. [email protected]

D. SCHEDULED PROCESS- Container dimensions- Capacity units

Purwiyatno [email protected]

D. SCHEDULED PROCESS- Container dimensions- Capacity units

Purwiyatno [email protected]

Page 23: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

23Purwiyatno Hariyadi …. [email protected]

D. SCHEDULED PROCESS- Container dimensions- Capacity units

Purwiyatno [email protected]

D. SCHEDULED PROCESS- Scheduled Process

Purwiyatno [email protected]

Page 24: (Form FDA 2541 dan FDA 2541a) - seafast.ipb.ac.idseafast.ipb.ac.id/lectures/thermal/13-ITP730-Faktor-Kritis-Proses... · digunakan dalam menyusun SOP (scheduled process) tetap dipelihara

24Purwiyatno Hariyadi …. [email protected]

D. SCHEDULED PROCESS- Other Critical Factors

Purwiyatno [email protected]

D. SCHEDULED PROCESS- Comments, Etc

Purwiyatno [email protected]

Terimakasih