Preventive Maintenance Procedures for Equipments and Machines
Session 10: Preventive Maintenance Procedures for
Equipments and Machines
Total Session Time: 120 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Osmosis Machine, Distiller, Autoclave, De-ionizer etc.)
Resources Needed:
SESSION OVERVIEW
Activity/
Step Time Content
Method
1 05 minutes Presentation Introduction, Learning Tasks
45 minutes Presentation Importance of Proper Preventive
2
Buzzing Maintenance of Equipment and Machines
10 minutes General Considerations in Preventive
3 presentation
Maintenance of Machines and Equipment
50 minutes Presentation Preventive Maintenance Procedures for
4
Brainstorming Equipment and Machines
5 05 minutes Presentation Key Points
6 05 minutes Presentation Evaluation
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing.
STEP 2: Importance of Proper Preventive Maintenance of Equipment
and Machines (45minutes)
Activity: Buzzing (5minutes)
ASK students to pair up and buzz on the following questions for 5 minutes
ALLOW few pairs to respond and let other pairs add on points not mentioned
WRITE their response on the flip chart/board
CLARIFY and SUMMARIZE by using the content below
minimal cost
working order so that a system can perform as intended
o To avoid production or service disruptions
o To not add production or service costs
o To maintain high quality
o To avoid missed delivery dates
plant or equipment to avoid the associated costs
become big issues OR involves maintenance performed to extend the life of the device
and prevent failure
with day to day problem of keeping the physical plant in good operating condition”
o Result of planned inspections
o According to calendar
o After predetermined number of hours
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
o Breakdown maintenance or corrective maintenance; Occurs when there is a work
stoppage due to machine breakdown
o Preventive maintenance; It is undertaken before the need arises and aims to minimize
the possibility of un -anticipated production interruption or major breakdowns
o Predictive maintenance; Conditions can be measured on a continuous basis and this
enables the maintenance people to plan for an overhaul.
o Routine maintenance; this includes activities such as periodic inspection, cleaning,
lubrication and repair of production equipments after their service life
o Planned maintenance; : it involves the inspection of all plant and equipments,
machinery, buildings according to a predetermined schedule in order to service
overhaul, lubricate or repair, before actual break down or deterioration in service
occurs
o To achieve product quality and customer satisfaction through adjusted and serviced
equipment
o Maximize useful life of equipment
o Keep equipment safe and prevent safety hazards
o Minimize frequency and severity of interruptions
o Maximize production capacity – through high utilization of facility
o Reduces break down and thereby down time
o Lass odd-time repair and reduces over time of crews
o Greater safety of workers
o Lower maintenance and repair costs
o Less stand-by equipments and spare parts
o Better product quality and fewer reworks and scraps
o Increases plant life
o Increases chances to get production incentive bonus
o Dependability of service
o Assured quality
o Prevent equipment failure
o Cost control
o Huge investment in equipment
STEP 3: Considerations in Preventive Maintenance of Machines and
Equipment (10 minutes)
o Proper design and installation of equipment
o Documentation on Predictive Maintenance
o Periodic inspection of plant and other equipments if properly functioning
o Repetitive servicing and overhaul of malfunctioning equipment
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
o Adequate lubrication, cleaning and painting
o Using of Personal Protective Equipments (PPE)
o Preventive maintenance Benefits and Control
STEP 4: Preventive Maintenance Procedures for Equipment and
Machines (Reverse Osmosis Machine, Distiller, Autoclave, (50 minutes)
Activity: Brainstorming (5 minutes)
Ask students to brainstorm on the following question:
ALLOW few students to respond
WRITE their responses on the flip chart/ board
CLARIFY and SUMMARISE by using the content below
o Design, Construction and Preventive maintenance of USP Purified Water Systems
o Reverse Osmosis (RO) is a well-established process
o For an RO system to work reliably and economically, the unit and associated
equipment must be routinely maintained
o Reverse osmosis is the most economical method of removing up to 99% of feed water
contaminants
o Requires pretreatment to avoid damaging the membrane;
o A Typical reverse osmosis preventive maintenance Checklist must be present in the
pharmaceutical preparation unit to avoid damaging of the membrane ,maintain
efficiency of the reverse osmosis machine and to ensure quality of the out coming
water:
o Test RO feed water
o Chlorine and water hardness content
o Check and set pretreatment filter and water softener clocks
o Log RO pump pressure, flow rate and temperature
o Test RO product water and log flow rates
o Test RO reject water and log flow rates
o Log Recovery %
o Log Rejection %
o Log pressure gauge readings.
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
o Change RO pre-filters
o Check salt/ chemical tank levels and add as needed
o Repair any minor leaks.
o Update PM Logs
o Monitor the incoming and outgoing water pressures through the Multi-media Filters,
Activated Carbon Filters, UV Systems, Pre-filter to the RO Units to assure the there
is adequate pressure to operate each piece of equipment as designed.
o This includes monitoring the filter unit during the backwash mode and while the
other unit is on line to provide flow to the RO System.
o If necessary, adjust the separate source backwash pressure coming from the domestic
water side in order for the diaphragm valves located on the filters to work properly
During the backwash phase take off the tubing to the valves, one at a time to verify
that there is hydraulic pressure going to the valve in order for the valve to work
properly.
o Monitor each control device during operation to include the controllers located on the
Filters, the display panel on the UV units, the control panel on the RO unit, and the
control panel located on the Chorine Monitoring Skid.
o Make any necessary adjustments to the operation of the equipment if there are
changes to the incoming water that would include a change in water quality and
temperature that would affect the operation of the RO Units and the chlorine feed
system that chlorinates the product water going to the storage tanks.
o Make adjustments to the chemical feed system to assure that the compound is
o The onsite chlorine test will be taken with a hand held calibrated DPD test kit to
provide accurate analysis.
o Provide onsite water analysis of the incoming raw water, the reject water from the RO
unit, and the product water from the RO unit with a hand held calibrated instrument to
determine if the RO unit is performing in accordance with specifications.
o All services will be performed by a competent Stateside Licensed Water Treatment
Plant Operator
o Autoclave operators should perform the following preventative maintenance on their
autoclave to maintain the autoclaves effectiveness:
o Remove the plug screen or drain strainer to make sure it is free of dirt, dust, or
sediment that may collect in it and it should be cleaned as necessary.
o Clean the interior surfaces of residues collected from the steam or materials being
sterilized as needed.
o Visually inspect the gaskets, doors, shelves and walls for residue build up or wear
regularly.
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
o The maintenance depends on the design and capacity of the distiller. The
maintenance of a distiller equipped with a stainless steel vapour generator tank with
immersion resistors and a condenser refrigerated through a ventilator impelling air
o Distiller operators should perform the following preventative maintenance on their
distiller to maintain the distiller effectiveness;
Inspection and cleaning of the vapor generator tank- Clean accumulated deposits.
In general, the cleaning process requires a chemical product especially designed
for removing them.
Change of the activated carbon filter-every three months, Install a new element
with the same characteristics as the original.
Cleaning of the condenser –annually, remove the condenser. Aspirate dirt, and
dust
accumulated on the surface of the diffusing fins. Compressed air or a brush
dampened with soap and water can also be use
Sterilization of the distilled water storage tank- Before operating a new water
distiller, it is recommended to insure that the distilled water storage tank is sterile
and clean. To carry out the sterilization, use a chemical process with domestic
bleach (chlorine based)
STEP 5: Key Points ( 5 minutes)
in the plant or equipment to avoid the associated costs
with day to day problem of keeping the physical plant in good operating condition”
STEP 6: Evaluation (5minutes)
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
References
maintenance of equipment and machines
Lund, W. (2009). The pharmaceutical codex: Principles and practice of pharmaceutics. New
Delhi: CBS.
amm, G., hler, . . Manual for decentralized infusion production: Infusion Unit
Project, Tanzania. Erscheinungsort nicht ermittelbar: Verlag nicht ermittelbar.
Aulton, M. E., & Taylor, K. (2018). Aulton s pharmaceutics: The design and manufacture of
medicines. Edinburgh: Elsevier.
Signore, A. A., & Jacobs, T. (2017). Good design practices for GMP pharmaceutical
facilities. Boca Raton, Fl.: CRC Press.
Gad, S. C. (2008). Pharmaceutical manufacturing handbook production and processes.
Hoboken, NJ: Wiley-Interscience.
Cooper, J. W., Gunn, C., & Carter, S. J. (1987). Dispensing for pharmaceutical students.
Edinburgh: Churchill Livingstone.
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PST 05207 Quality Assurance of Pharmaceutical Products NTA Level 5 Semester 2
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