PENGURUSAN PERALATAN MAKMAL

Transcription

1 PENGURUSAN PERALATAN MAKMAL Manage with style NOR NADIA ALIES 27 MAC 2018

2 PHARMACEUTICAL PILOT PLANT Department of Pharmacy Faculty of Medicine University of Malaya

3 LET S HAVE SOME FUN!!!

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5 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?

6 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?

7 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.

8 TIPS WH questions Wh-questions begin with what, when, where, who, whom, which, whose, why and how. We use them to ask for information

9 WHY EQUIPMENT MANAGEMENT? 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

10 QUALITY MANAGEMENT SYSTEM PLANNING should go into equipment management! Equipment Management begins from??

11 A GREAT DEAL OF THOUGHT.. 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?

12 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?

13 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

14 SELECTING EQUIPMENT 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?

15 INSTALLING 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

16 GETTING THE EQUIPMENT READY 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

17 GETTING THE EQUIPMENT READY SOP IQ PQ OQ

18 IMPLEMENTING AN EQUIPMENT MAINTENANCE PROGRAM Includes measures such as systematic and routine cleaning, adjustment and replacement of equipment parts at scheduled intervals (daily, weekly, 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

19 TROUBLESHOOTING, SERVICE, REPAIR, AND RETIRING EQUIPMENT 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

20 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

21 EQUIPMENT MAINTENANCE DOCUMENTATION 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

22 THE 5 SENSES

23 EQUIPMENT MANAGEMENT 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

24 EQUIPMENT MANAGEMENT Weighing machine -open pan -close pan -Calibration kit

25 EQUIPMENT MANAGEMENT

26 EQUIPMENT MANAGEMENT Water bath-regular water change and cleaning of your bath is needed to preserve the baths corrosion resistance

27 EQUIPMENT MANAGEMENT

28 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.

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

30 WHAT IS THE BENEFITS 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

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33 THE END