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Equipment

Principle Equipment must be

located

designed

constructed

adapted

maintained

to suit their intended use

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Equipment

Principle

Equipment layout and design must aim:

to minimize risks of error

to permit effective cleaning

to permit effective maintenance And to avoid:

cross-contamination

dust and dirt build-up

any adverse effect on the quality of products Equipment must be installed to:

minimize risks of error

minimize risks of contamination

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Equipment

Pipesand pipings

Fixed pipework:

clearly labelled

indicate contents

direction of flow Service pipings

adequately marked

non-interchangeable connections or adaptors

Dangerous gases and liquids

http://localhost/var/www/apps/conversion/risye%20ferron/ppt/Training%20BOT%20Pabrik.ppthttp://localhost/var/www/apps/conversion/risye%20ferron/ppt/Training%20BOT%20Pabrik.ppt

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PIPA2 & KABEL2 HARUS DIBERI PENANDAAN DAN DIBERI LANDASAN

Bangunan/Lafial/TP/11-2006

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Equipment

Balances and Measuring Equipment

Appropriate range

Precision

Available to:

production quality control

Calibrated

scheduled basis

checks

records maintained

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Equipment

Production equipment Design easily and thoroughly cleaned

scheduled basis

Location Maintenance

No hazard to the products suitable non-reactive materials

non additive

not absorptive

Defective equipment removed

labelled

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Equipment

Control laboratory equipment

Equipment and instruments: suitable for the tests to be performed

Defective equipment removed

labelled

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Equipment

Washing and Cleaning

Design promotes easy cleaning

On scheduled basis

Washing and cleaning equipment:

Manual

Automated (Clean in place (CIP), Steam in place

(SIP))

Not the source of contamination

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Disain dan pemilihan peralatan Mudah dibongkar- pasang dan dibersihkan Tidak menahan sisa produk dan larutan pencuci , tidak boleh ada dead

leg

Tidak mudah berkarat dan tergores Inert

Dapat digunakan : S/S AISI 304/316 , gelas , bahan inert , teflon ,

politetraflouroetilen dll

kedap ledakan ( explosion proof ) , dibumikan

Pemasang dan penempatannya :

mencegah pencemaran silang , leluasa bergerak dan untuk bekerja , diberitanda pengenal / kartu perawatan

Program perawatan mesin ( Preventive Maintenance Program )

Protap perawatan , jadwal perawatan , didokumentasikan

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ValidasiUntuk memberikan kepastian bahwa peralatan sudah berfungsi sesuai

dengan kegunaannya

Dibuat Protap , program & protokol validasi , catatan , dievaluasi/koreksi

KalibrasiHasil pengukuran dibandingkan terhadap ukuran baku

Dibuat Protap , program validasi , catatan , dievaluasi/koreksi

Tera

Alat timbang harus diterakan tahunan oleh Dit. Metrologi

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Equipment

Possible Issues Poor design Lack of safety Poor quality finishes Lack of cleaning Lack of maintenance No usage log or record Use of inappropriate weighing equipment Open-plan location of compressing machines

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