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Cdob 2012 pdf

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CPOB - BAB 1 QMS. Deviation – Change. PQR . Peraturan Ka BPOM RI / , tentang Penerapan. Pedoman CPOB. ○ Peraturan Ka. Badan POM RI Pedoman Cara Distribusi Obat yang Baik CDOB Badan Pengawas from PHARMACY at Sanata Dharma University. Download as PPT, PDF, TXT or read online from Scribd. Flag for . 5 8 FEB APOTEK, APOTEK RAKYAT & CDOB- . Cara Distribusi Obat yang Baik Edisi


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(Cara Distribusi Obat yang Baik/CDOB) in and Regulation of the. Minister of system in PHCs using checklists developed based on CDOB and PMK. for Pharmaceutical Products (Cara Distribusi Obat yang Baik/CDOB) in Data were collected by observing the vaccine distribution system in PHCs using checklists developed based on CDOB and PMK 42/ Full Text: PDF . Good Pharmaceutical Distribution Practice is called as CDOB in Indonesia is a guidelines to ensure Indonesia Nomor HK tahun tentang pedoman teknis cara distribusi obat yang baik. PDF (Bahasa Indonesia).

Technical suplement to WHO technical report series, No. Collodions 4. New York: CDOB certifi cation however, just became mandatory in November Softening range; appearance and melting. Walaa Mahrous. Jump to Page.

Profil Kesehatan Indonesia. Kementerian Kesehatan Republik Indonesia, Jakarta; Module VMH-E How to monitor temperatures in the vaccine supply chain.

CPOB Liquid dan Semi Solid | Quality Assurance | Topical Medication

The impact of health facility monitoring on cold chain management practices in Lagos , Nigeria. Kesehatan RI D. Pedoman Pengelolaan Vaksin. Departement of Immunization V and B.

Geneva, Switzerland: World Health Organization; Published by: User Username Password Remember me. Article Tools Print this article. Indexing metadata. How to cite item. Supplementary files. Email this article Login required.

Vaccines distribution system at primary healthcares in the special region of Yogyakarta Dian Medisa, Diesty Anita Nugraheni. Abstract Background: Keywords cold chain; vaccine; distribution system; primary healthcare; Yogyakarta. Semua bahan yang digunakan untuk mengemas produk. Untuk memudahkan distribusi produk dan untuk melindungi produk dari pengaruh lingkungan. Bahan pengemas primer: Bahan pengemas yang berkontak langsung dengan produk alufoil, blister, botol, vial dan ampul.

Karena berkontak langsung dengan produk, proses pengemasan primer harus dilakukan di area pengolahan, tidak boleh dilakukan di area pengepakan. Bahan pengemas sekunder: Bahan pengemas yang tidak berkontak langsung dengan produk. Unit box, dus, corrugated box.

Sejumlah tertentu obat yang memiliki sifat dan mutu yang seragam. Dibuat atas satu perintah produksi: Satu batch produk tidak boleh dicampurkan dengan batch lain Kecuali ada persetujuan manager QC.

Perlu didukung dengan alasan yang jelas, dan pembuktian. Bagian dari batch yang memiliki sifat dan mutu yang seragam. Dalam proses pengolahan suatu produk dapat ditemui tahapan yang mengharuskan untuk membagi batch kedalam beberapa bagian Misalnya: Batch tidak dibagi kedalam Lot apabila hasil akhirnya dicampurkan. Sebelum bagian-bagian batch dapat dicampurkan, harus. Bahan baku, bahan pengemas, dan produk jadi. Produksi - Laktam ; non - Laktam: Sefalosporin; Hormon estrogen.

Ruang terpisah: Pembagian kelas berdasarkan: Jumlah partikel terutama Tingkat kebersihan Jumlah mikrobanya. Secara teknis tiap kelas berbeda pada: Konstruksi Material Sistem pengendalian udara. Kelas hitam digunakan untuk: Penanganan produk ruahan yang sudah tertutup kemasan primer: Digunakan untuk pengolahan produk steril Merupakan kelas yang tertinggi tingkat kebersihannya, baik dari segi partikel ataupun jumlah mikrobanya.

Pakaian kerja khusus Baju, celana, sepatu Tutup kepala, masker Sarung tangan, goggle kaca mata. In operation 0,5mm 3 3 Not defined Not defined 5mm 0 20 Not defined Not defined. Ruang pengemasan sekunder tidak berhubungan langsung dengan area luar; untuk memasuki ruang ini disarankan melewati suatu ruang penyangga udara airlock atau ruang antara ante- room.

F ruang pengemasan sekunder Tidak ditetapkan Tidak ditetapkan Tidak ditetapkan Tidak ditetapkan. Bingkai P.

Pallet P. Jenis pengaduk P. Gate paddle P.

PENGANTAR CDOB.ppt

Digunakan dalam proses homogenisasi kontinu thd produk bkuantitas besar dalam waktu relatif singkat. The colloid mill is a fluid ultramicro smashing machinery.

Pdf cdob 2012

It performs the functions of smashing, emulsification, dispersing, homogen, milling and so on. Chemical industry: Biological products, vaccine, medicinal ointment, each kind of oral liquid Daily expenses industry: The Choice of Filling Machine Depends on: The range of viscosity of the liquid Temperature Chemical compatibility Particulate size Foam characteristics and Hazardous environment considerations.

Commonly Used Filling Machines Overflow liquid filling machines: These are commonly used in small bottle filling operations and the machine is also able to handle liquids with medium viscosity. Servo pump liquid filling machines: These machines are very versatile liquid filling machine capable of filling nearly any type of product that can be pumped. Peristaltic filling machines: This specially designed filler machine is used to fill liquids of high value and small volume of liquids fills with high accuracy.

Commonly Used Filling Machines The gravity liquid filling machines: This is the most economical type of liquid filling machine for a limited range of applications.

Piston liquid filling machines: These machines are one of the oldest and most reliable types that are used in the packaging industry.

Net weight liquid filling machines: This type of filler is best suited for liquids that are required to fill in bulk quantities. For liquids with low to medium viscosity. Note that overflow fillers are the machine of choice in handling very foamy products at higher speeds. Sauces, syrups, light gels and shampoos, foamy cleansers and chemicals, water and other non carbonated aqueous beverages. High performance, easy to clean, easy to operate, expandable at low cost.

Offers greatest flexibility at lowest cost. The supply side dark blue of a two part nozzzle is used to pump product into the container. When the container fills up to the target fill height, the excess product and foam is forced out of the container red arrows via the return side to the original product source tank. Both thin and thick products, and also very large particulates can all be filled on this machine. Cosmetic creams as well as thick, chunky sauces at pasteurized temperatures can all be filled.

Fill size changeovers are practically infinite and are instantaneous by computer control.

Operator setup is greatly simplified. The design also lends itself very well to sanitary applications due to the ease of automatic cleaning. The filler's master computer independently tracks the rotation of each pump head so that it knows precisely how much product has been delivered.

When the target fill volume is reached, each pump and nozzle is instantly shut off, resulting in high accuracy fills of your valuable products. The computer stores all fill parameters in memory for fast changeovers. Specifically designed for high value, small volume fills at very high accuracy. Suitable for aqueous and other light viscosity products. Pharmaceutical preparations, fragrances, essential oils, reagents, inks, dyes, and specialty chemicals.

Fluid path is disposable; easy cleanup and elimination of cross contamination problems. Accuracies of 0. The peristaltic pump makes intermittent contact on only the outside of the surgical product tubing so that the product only touches the inside of the tubing.

The filler's master computer independently tracks the of rotations of the peristaltic pump head so that it knows precisely how much product has been delivered. When the target fill volume is reached, the pump stops and the remaining product fluid does not drip out due to pipette action. For liquids with very thin viscosities that do not change with ambient temperature or with batch variation.

This machine is also suited for applications where recirculation of the liquid in the fluid path is not desireable. Water, solvents, alcohol, specialty chemicals, paint, inks, corrosive chemicals i. This is the most economical type of filling machine for a limited range of applications. It is especially well suited for corrosive chemicals. The product bulk supply is pumped into a holding tank above a set of pneumatically operated valves. Each valve is independently timed by the filler's master computer so that precise amounts of liquid will flow by gravity into the container.

Gravity fillers built with bottom up fill capability can handle a wide range of flowable liquids including foamy products. This type of piston filler is best suited for viscous products that are paste, semi paste, or chunky with large particlates.

Heavy sauces, salsas, salad dressings, cosmetic creams, heavy shampoo, gels, and conditioners, paste cleaners and waxes, adhesives, heavy oils and lubricants. This lower cost conventional technology is easy to understand for most users. Fast fill rates are achievable with fairly thick products. The piston is drawn back in its cylinder so that the product is sucked into the cylinder.

A rotary valve then changes position so that the product is then pushed out of the nozzle instead of back into the hopper. For liquids filled in bulk quantities e. Volumetric Fillers are ideal for filling liquids with low to medium viscosity.

There are tube filling machines used for filling viscous and semi viscous products. These machines are operated using volumetric displacement pump based filling system.

Manual Volumetric Filling Machines: As the name suggests, they are operated manually. Liquid Generally glass has been the material of choice for the packaging of liquid Variety plastics used they have little or no permeability to the liquid Semisolid flexible tubes made from aluminium or plastic such as PE.

Cold - any temp not exceeding 8oC 46oF - a refrigerator is a cold place where the temp. Room Temp. Oral Solutions and Suspensions: Appearance, precipitation, pH, color, odor, dispersibility suspension and clarity solutions Topical creams: Appearance, color, homogeneity, odor, pH, resuspendability lotions , consistency, particle size, distribution strength, weight loss. Opthalmic and Nasal and Oral inhalation preparations: Appearance, color consistency, pH, clarity solutions , particle size, and resuspendability suspensions, ointments , strength and sterility.

Softening range; appearance and melting. Appearance such as phase separation color, odor, pH, and viscosity. Flag for inappropriate content.

Badan pom ri 2012 pedoman cara distribusi obat yang

Related titles. Regulations Concerning Airborne Particle Counting 1. Prerequisite Technique on the Fish Processing Units. Jump to Page. Search inside document. Yoga Windhu Wardhana Zat aktif sulit untuk langsung digunakan krn. A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect. Dalam CPOB dikenal 3 jenis penyebab kontaminasi: Bahan kimia Mikroba Partikel asing Pelanggaran dapat mengakibatkan: Teguran Penarikan kembali obat yang beredar recall Penutupan pabrik Sanksi tersebut dikenakan karena pemerintah bertanggung jawab untuk melindungi kesehatan masyarakat pemakai obat kita.

2012 pdf cdob

Waktu penyesuaian pemenuhan CPOB Semua bahan baku dan bahan pengemas yang digunakan dalam produksi obat. Terdiri dari: Bahan pengemas primer Bahan pengemas sekunder Bahan pengemas primer: Bahan pengemas yang berkontak langsung dengan produk alufoil, blister, botol, vial dan ampul Karena berkontak langsung dengan produk, proses pengemasan primer harus dilakukan di area pengolahan, tidak boleh dilakukan di area pengepakan.