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B. Venkateswara Reddy
Santhiram College of Pharmacy
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Review Article
Available online at www.JGTPS.com
ISSN: 2230-7346
Journal of Global Trends in Pharmaceutical Sciences
Volume 5, Issue 1, pp-1450-1459, January-March 2014
A REVIEW ON QUALIFICATION OF AUTOCLAVE, RMG, FBD, CONE BLENDER,
TABLET COMPRESSION MACHINE
B.Venkateswara Reddy*1, ABSTRACT
B.Rasmitha Reddy1,
K.Navaneetha1, Validation is one of the important steps in achieving and
maintaining the quality of the final product batch after batch. Without
K.Venkata Ramana Reddy2
equipment, we cannot manufacture a product. If equipment is validated,
1 we can ensure that our product is of the best quality. Validation of the
St.pauls College of Pharmacy,
equipment is called the Qualification. To manufacture different types of
Turkayamjal, R.R (Dist) -501510 dosage forms, different equipments are used. Here, this article
2
Sree Datta Institute of concentrates on the equipment qualification for RMG, FBD, and
Pharmaceutical sciences, Blender & Compression Machine. It gives in detail, qualification
Sheriguda, R.R (Dist)-501510 steps of the equipment which is used for manufacturing process
through wet granulation
E-mail: basu.pharmacist@gmail.com
Keywords: Validation, Equipment Qualification, RMG, FBD, Blender
Journal of Global Trends in & Compression Machines.
Pharmaceutical Sciences
INTRODUCTION: been made mandatory by the regulatory bodies
In manufacturing facilities, validation to prove the safety, efficacy, purity &
test procedures are used to validate equipment effectiveness of the drug product, medical
and processes that may influence product devices & biologics in the market place &
quality. The tests for validation are used in health system.
accordance with approved written qualification IMPORTANCE OF VALIDATION
procedures. All necessary activities and Increased throughput
responsibilities for the qualification and Reduction in rejections and reworking
validation are controlled and specified in this Reduction in utility costs
Validation Master Plan. Every step of the Avoidance of capital expenditures
described validation program for facilities, Fewer complaints about process-related
equipment, processes, process controls, and failures
cleaning is in accordance with the current Reduced testing in-process and in finished
European Community Guidelines for GMP and goods
FDA, and the cGMP guideline for finished
More rapid and reliable start-up of new
pharmaceutical manufacturers
equipment
DEFINITION:
Easier scale-up from development work
Validation may be defined as
Easier maintenance of equipment
“Establishing documented evidence which
provides a high degree of assurance that a Improved employee awareness of
specific process will consistently produce a processes
product meeting its pre-determined More rapid automation
specifications and quality attributes.” It has EQUIPMENT QUALIFICATION
Qualification: Action of proving and
Address for correspondence documenting that equipment or ancillary
B. Venkateswara Reddy* systems are properly installed, work
St.pauls College of Pharmacy, correctly, and actually lead to the expected
Turkayamjal, R.R (Dist) -501510 results. Qualification is part of validation, but
B. Venkateswara Reddy et al/JGTPS/Volume 5, Issue 1, January-March 2014
1450
Journal of Global Trends in Pharmaceutical Sciences
Verify that the utilities required are Delay time for achieving constant air
available. conditions
Installation shall be conducted per
instructions provided in the manual. Procedure
Ensure that all relevant documentation is Determine, by use of a thermocouple and a
received: hygrometer, the necessary delay time required
User manual at an adjusted inlet air temperature (in relation
Maintenance manual to granulating processes) for reaching
List of change parts constant air conditions. Determine these
figures for first use of the equipment at the
Electrical drawings
Instruments for measuring temperature, working day, as well as for further use of the
humidity, time, air volume and pressure, as equipment at the same working day.
well as recording devices for these variables, Also calculate from the obtained data the water
should be calibrated. content of the inlet air (g water/kg air) and
Air temperature distribution Place compare to the requirements.
several thermocouples at different locations in Equipment identification:
an empty fluid bed drier, e.g.: Record the
Equipment identification number
Inlet air channel below product container
Equipment manufacturer
mesh bottom
Purchase order
Product container
Model number
Below filter bag Equipment number
Above filter bag
Exhaust air channel Required documentation:
Measure the temperatures, letting in air of a The manufacturers operation and maintenance
constant temperature (e.g., 60°C). manual and SOPs that cover the set up.
Inlet air installation
Equipment Utility Requirements:
Delay time for achieving constant air Compare the manufacturer's specified
conditions Determine, by use of a requirements to their as found conditions
thermocouple and hygrometer, the necessary at the time of qualification testing.
delay time required at an adjusted inlet air Power
temperature (in relation to drying processes)
Steam
for reaching constant air conditions. Determine
Compressed air
these figures for the first use of the equipment
Calibration
at the working day, as well as for further use of
the equipment at the same working day. Ammeter
Also calculate from the obtained data the water Air/ water
content of the inlet air (g water per kg air) and Pressure gauge
compare with the previously fixed Temperature gauge
requirements. Major component specifications:
Microbiological quality of the inlet air Motor
Determine, by use of a bio test RCS centrifugal Fan: mfg, location, no of blades, rotation,
air sampler, the microbiological quality of the capacity
inlet air. Ducting systems : material, type,
Sampling time 5 min = 8:1 air welding, type of welding, no of weld
Requirements spots
200 CFU/m inlet air Heater: voltage/ capacity
Influence of weather on inlet air conditions Air heaters: coils
Inlet air installation Product container: housing, material, type
of discharge port.
Test Functions
1. Perform Installation Qualification. Verify
equipment identification, required Figure 7: Components of tableting equipment
documents, utilities, manual, and drawings.
2. Verify components material. Installation Qualification:
3. Verify equipment safety features.
4. Operate the blender throughout the range
of operating design specifications or range
of intended use direction, and motor fixed
speed.
5. Verify equipment switches, push-buttons,
and rotation
6. Perform the assay to check the content Figure 8: IQ elements of a tablet press
uniformity on blended granules at different
locations. The supporting electrical utilities must meet all
electrical codes.
Acceptance Criteria: The information required for an IQ
1. The system is installed in accordance evaluation is equipment identification,
with design specifications, manufacturer required documentation, equipment utility
recommendations, and cGMPs. requirements, major component
Instruments are calibrated, identified, and specifications, component material, lubricants
entered into the calibration program. and equipment safety features.
2. General alarms and controls operate in
accordance with design specifications. Equipment Identification:
3. The system operates in accordance with Record the equipment identification numbers,
design specifications throughout the along with the following information:
operating range or range of intended use. Model number
4. The safety devices operate as specified in Serial number
the manual. Company assigned equipment number and
5. The quality of lubricants is adequate and Location of the equipment
the lubricants are properly stored.
6. Unauthorized changes to cycle parameters Required Documentation:
are not allowed without supervisory Record the equipment manufacturer's operation
control or password. and maintenance manual and drawings. Record
7. Assay results should be within the the SOP that cover the setup, operation and
specifications. cleaning of the tablet press.