PENGURUSAN PERALATAN MAKMAL

“Manage with style”

NOR NADIA ALIES

27 MAC 2018

PHARMACEUTICAL PILOT PLANT

Department of Pharmacy Faculty of Medicine

University of Malaya

LET’S HAVE SOME FUN !!!

Adi has to build an ark. He is told to collect every single

animal on earth, not just two of each. Every animal boards the

ark, except for one. Which animal does not board the ark?

There is a river you must cross. However, the river is inhabited

by crocodiles. How do you cross the river without being

killed by the crocodiles?

How do you put a giraffe into a refrigerator? Answer : You open the refrigerator, put in the giraffe, and lose the door. This question tests whether you tend to do simple things in an over

complicated way

How do you put an elephant in to a fridge? Answer: Open the refrigerator take out the giraffe, put in the elephant,

and close the door This tests your ability to think about the repercussions of your action

Adi has to build an ark. He is told to collect every single animal on earth, not

just two of each. Every animal boards the ark, except for one. Which animal does not board the ark?

Answer: The elephant, as it is still in the refrigerator. This question tests your memory.

There is a river you must cross. However, the river is inhabited by crocodiles.

How do you cross the river without being killed by the crocodiles? Answer : You simply swim across. There is no danger as the crocodiles are

on Adi’s ark. This question tests whether you learn quickly from your mistakes.

WH – questions Wh-questions begin with what, when, where, who, whom, which, whose, why

and how. We use them to ask for information

TIPS…

One of the essential elements of a quality management system

Proper management of the equipment in the laboratory is necessary to ensure

accurate, reliable, and timely testing

WHY EQUIPMENT MANAGEMENT?

PLANNING should go into equipment management !

Equipment Management begins from……??

QUALITY MANAGEMENT SYSTEM

Elements should be considered:

Selection and purchasing-to purchase or to lease? High end QTOF, LC, NMR, GPC ex: column

Installation – what are the requirements?

Calibration and performance evaluation – What is needed so that the instrument operating correctly?

Maintenance – what maintenance schedule recommended?

A GREAT DEAL OF THOUGHT..

Troubleshooting – Is there a clear procedure for troubleshooting for each instrument?

Service and repair – What is the cost? Is the services available in its geographical area?

Retiring and disposing of equipment – what must be done to dispose ?

A GREAT DEAL OF THOUGHT..

Equipment management responsibility may be specifically assigned to a technologist in the laboratory

Appropriately trained and understand how to operate the instrument and perform routine maintenance procedures

Monitoring activities:

Review equipment records routinely

Update maintenance procedure as necessary

Ensure that all procedures are followed

Selecting the best instrument – very important

Criteria to be consider Why and how will the equipment be used? Should match service

provides

What are the performance characteristics of the instrument/spec.? Suit the needs of the testing?

What are the facility requirement? Physical space?

Does the equipment have a warranty?

Are there any safety issues to consider? Ex Fluid Bed Dryer

Will instruction be available in a language that is understood

The manufacturer should provide all the info

Is it better to purchase or lease?

SELECTING EQUIPMENT

Laboratory provide all the necessary physical requirement

Electricity

Water

Space

Adequate room to move the equipment into the lab, consider door openings and elevator access

It is best to have the manufacturer to install laboratory equipment; this will likely improve the conditions of the

warranty and ensure the installation is done properly and quickly

INSTALLING EQUIPMENT

The following details need to be addressed before putting the equipment into service: Assign responsibility for performing maintenance &

operation

Implement a written plan for calibration, verification & operation

Establish scheduled maintenance program daily, weekly or monthly

Training for all operators

Run the instruments with the test kits provided by the manufacturer. Follow the instruction. Compare with the results provided by the manufacturer. Documentation : OQ, PQ, IQ

GETTING THE EQUIPMENT READY

SOP

IQ

PQ

OQ

GETTING THE EQUIPMENT READY

Includes measures such as systematic and routine cleaning, adjustment and replacement of equipment parts at scheduled

intervals (daily, weekly, monthly, @ yearly)

It is recommended that a label be attached to the instrument indicating when the next maintenance or service should be performed

Equipment inventory log, should have record: Type, serial number, made and model number, date equipment purchase, manufacturer/vendor contact, presence and absence document, warranty’s expiration, etc to ensure the lab does not run out of spare parts

IMPLEMENTING AN EQUIPMENT MAINTENANCE PROGRAM

Problems with equipment may present in many ways

Operator notice and take action, troubleshoot and preventive maintenance procedure to solve problem

Questions:

Is the problem related to poor sample?

Is there a problem with water, air or electrical supply?

Make one change at a time based on symptoms. If the equipments is the problem, review manufacturer’s instructions to verify that all procedures are being followed correctly

IF PROBLEM CANNOT BE IDENTIFIED FIND BACK UP INSTRUMENTS

TROUBLESHOOTING, SERVICE, REPAIR, AND RETIRING EQUIPMENT

Do NOT use faulty equipment

Seek help from manufacturer or other technical expert

Place a note on the equipment so all staff are aware

WARNING : OUT OF ORDER DO NOT USE (DATE)

It is important to have policy and procedure for retiring older laboratory equipment. This will usually occur when it is clear

that the instrument is not functioning and is not repairable or outmoded

Disposed- often neglected, taking up valuable spaces and creating hazard

TROUBLESHOOTING, SERVICE, REPAIR, AND RETIRING EQUIPMENT

IMPORTANT : keeping good equipment record will allow for through evaluation of any problem arise

Logbook documenting all characteristics and maintenance elements (Preventive maintenance activities, recording

function checks, calibration, maintenance by the manufacturer, full info on any problem that the instrument

develops, troubleshooting, follow up info, date problem occurred, reason breakdown, corrective action taken, date

returned, etc)

THE LOG BOOK SHOULD BE AVAILABLE FOR REVIEW DURING THE ENTIRE LIFE OF THE EQUIPMENT

EQUIPMENT MAINTENANCE DOCUMENTATION

THE 5 SENSES

Weighing Machine

Basic instrument BUT ……. Very sensitive

Where to locate?

On Solid bench that is AVT/stable

Not near to corner of the room/room access through a sliding door

Free from air/not near to ovens

EQUIPMENT MANAGEMENT

EQUIPMENT MANAGEMENT

Weighing machine -open pan -close pan -Calibration kit

EQUIPMENT MANAGEMENT

EQUIPMENT MANAGEMENT

Water bath-Regular water change and cleaning of your bath is needed to preserve the baths’

corrosion resistance

EQUIPMENT MANAGEMENT

EQUIPMENT MANAGEMENT

pH meter-Dry storage causes dehydration of the glass electrode and the precipitation of salts within the interstices of the frit itself. The consequences are reading drift, slow response times and loss of accuracy and precision.

EQUIPMENT MANAGEMENT Air compressor-remove air when not in use Service + certificate from OSH Air tubing – fragile replacement/ once every 5 years

Helps to maintain a high level of laboratory performance

Reduces variation in the test results

Improves the technologist’s confidence in the accuracy of testing results

Lowers repairs cost, as fewer repairs will be needed for a well maintained instrument

Lengthens instrument life

Reduces interruption of services due to breakdown and failures

Increases safety for workers

Produces greater customer satisfaction

WHAT IS THE BENEFITS

THE END