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01/04/2017

TYPES OF STERILE PHARMACY INDUSTRY


PREPARATION: CPOB,cCPOB,
ISO,GMP, cGMP
- PARENTERAL SMALL VOLUME. PAR
LARGE VOLUME PAR
1. NON STERIL PRODUCT
- EYE PREPARATION EYE DROP,
PHARMACY PRODUCT: OINTMENT, COLLIRIUM/EYE WASH STERILITY TEST STERILIZATION
2. STERIL - IMPLANT TABLET
- SOME BIOLOGIC PREPARATION STERILE PRODUCT
- HEALTH TOOL
- ETC.

STERILE : QUALITY OF STERILE MANUFACTURING


- NOT ONLY DRUG BUT ALSO BEVERAGE , PRODUCT : PROCESS OF STERILE
HEALTH TOOL, ROOM, ETC MUST NOT DEPEND ON FINAL CONTROL PREPARATIONS
- DRUG LABEL : STERILE SHOULD BE TREATED EARLY
- STERIL UNDERSTANDING MUST BE • START PLANNING EARLY
− USING GMP/CPOB
ABSOLUTE, ALTHOUGH SAMPLE OF REQUIREMENT OF EMPLOYEES 1. TERMINAL STERILIZATION
STERILITY TEST IS LIMITED REQUIREMENT OF TOOL, PROCESS
- THE SAMPLE MUST BE REPRESENTATIVE STARTING MATERIAL,BUILDING 2. ASEPTICALLY PROCESS
ETC
- IT IS IMPORTANT TO WORK CAREFULLY

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01/04/2017

1.TERMINAL STERILIZATION PROCESS B. Example : ophthalmic ung


Active agent + Ingridient+ solvent--- Sol, 1.Active agent : sterilisation by radiation
Mix. Filter with Bacteria filter size 0,45 um, 2.Basic Ung : sterilization by Dry Heat
pour to the ampule or another packaging, 3. Campur ad homogeny, masukan wadah
closed. Sterilize with autoclave 121 oC , 15 Dilakukan di ruang kelas A ( ruang steril)
minute. ( Classroom used : D )
2. ASEPTICALLY PROCESS
A. Active agent + Ingridient+ solvent--- Sol,
Mix. Filter with Bacteria filter size 0,45 um,
filter with bacteria filter size 0,20 um , pour
to the ampule or another packaging, closed.

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