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Metrology
Bob OBrien
Dave Miller
NHCTC at Pease
Welcome to the Eggsentrix
Annual Stockholders Meeting!
Our mission: To meet or exceed our
customers expectations for highest
quality extra large eggs.
Al Bumen, CEO
Eggsentrix Inc.
The News
$
2005 2006
The Real Problem!
Calibration of the balance scale!
Over time, the measurements of an
instrument can become inaccurate. This
can be from
Wear
Misuse
Aging of components
Environmental changes
Stuff happens!
What Should Be Done?
????
System approach
Monitor/verify
Periodic maintenance
Periodic calibration
Scheduling
SOP
Documentation
QA
Traceability
Who Can Perform Calibrations
Instrument user
Line supervisor
Internal calibration team
External calibration service
Instrument manufacturer
In all cases, proper training and
documentation are required
Calibration Periods
Manufacturer-recommended calibration interval.
Before a major critical measuring project.
After a major critical measuring project.
After an event. If your instrument took a hit
Per requirements. Some measurement jobs
require calibrated, certified test equipment
Monthly, quarterly, or semiannually.
Annually.
Biannually.
Never.
PRINCIPLES OF A
CALIBRATION
MANAGEMENT
SYSTEM
Calibration Management
System (CMS)
Essential elements:
Trained personnel
Instrumentation assessment
Management
Documentation
Corrective action procedures
Features of a CMS
Identifies instruments that can be
calibrated
Determines calibration requirements for
instruments
Establishes calibration procedures
Develops corrective action procedures
Documents calibration results and
activities
Supports audit trails for calibration system
Purpose of a CMS
Defines:
What is required?
Who is responsible?
When does it need to be done?
Why does it need to be done?
How it is accomplished?
Important Definitions
Calibration: The operations which assure that an
instrument readings are accurate referenced to
established standards.
Validation: Proving that a system (equipment, procedure,
process, material) will yield expected results.
Qualification: Assuring that equipment can produce
expected results.
Instrument: A device which measures a parameter.
Test Equipment: Devices used during the calibration of
instruments. These devices must be traceable to known
standards.
Requirements for a CMS
Each instrument requires:
Unique identification
A recorded history and current calibration status
Use appropriate for the function of the instrument
Calibration procedures require
Approved procedures for calibration
Schedule for calibration
Process range limits
Calibration standards and test equipment
Must be more accurate than the required accuracy of the
instrument (typically 4 times more accurate)
Traceable back to national or international standards
Personnel
Proof of appropriate training
Perform within an established change management process
Establishing a Calibration
Management System
Criticality assessment
Life cycle phases
Project
Pre-Operational
Operational
Training
Change control
Documentation
Electronic Records
Auditing
Criticality assessment
Process owners, Engineering, and Quality
Assurance establish for all instruments
involved with the process and their
respective criticality
Identification, range, accuracy, history,
capabilities
Criticality and calibration rationale
Categorization (product critical, process
critical, safety critical, non critical)
Schedule for calibration service
Life cycle phases
Project: definines instruments to measure
process variables. Ensure proper selection of
instrumentation and procedures.
Pre-Operational: ensures transfer of calibration
data and historical information to the operational
phase. SOPs established.
Operational: calibration, cleaning,
decontamination, and documentation of the
process instrumentation.
Training
Ensure that all personnel involved with
calibration are properly trained
Training records must be maintained
Personnel and identification records
Future training needs
Qualification records
Experience records
Competence records
Courses and presentations
certificates
Change Control
Updates and refinements User requests change
of the calibration system
must be done in a Engineering defines detail
methodical and
documented manner QA approves change
F = 1.8 C + 32
K = C + 273
C = 1.8 F - 32
Measurement of Temperature
In industrial process controlled applications ,
temperature is one of the most frequency
controlled and measure variable in
biotechnology.
Transducers fall into two categories a direct
connected or inserted into the body to be
measured is a thermometer.
If the temperature is measured by observing the
body to be measure through indirect contact is a
pyrometer, by radiant heat or sensing the optical
properties of the body.
Transducers/ RTD
Calibration record: is the data taken during calibration.
Calibration curve is a line of connecting data points for a
particular transducer.
Static calibration: a calibration in which the transducer
is allowed to settle to a fixed value.
Dynamic calibration: is often a comparison of the
transducer that is being calibrated and that of a know
reference transducer.
Step-function response test: a rapid change is
introduced 10%-90% of transducer range. The time it
takes for the transducer to settle to new measured value
is a measurement of the response time.
Thermocouples
A thermocouple junction is created when two dissimilar metal wires
are joined at one end. When the junction is heated , a small
thermionic voltage that is directly proportional to the temperature
appears between the wires.
Type J thermocouples containing iron are relatively inexpensive but
limited range.
Type R and S thermocouples are (platinum-rhodium) are particularly
stable .
Type E thermocouple has advantages for measurement of low
temperatures but has a high non0linerarange.
Type w (tungsten-rhenium) thermocouples are suited for very high
temperatures.
Exposed-junction thermocouples are prone to corrosion and are
fragile, to help prevent these problems probes are sheathed probes
are made in metal or ceramic.
Thermocouple Meter
Digi-Sense* DuaLogR* Thermocouple Meters
Microprocessor-controlled TDS or
conductivity testers offer field durability, plus
1% full-scale accuracy
Automatic temperature compensation over
the entire 0 to 50C (32 to 122F) range for
quick response, even in fluctuating
temperatures
Unique electrode sensor-cup design allows
use as a conventional dip-style tester or as a
cup-style tester
Calibrate using the one-point, push-button
calibration feature
Environmental chamber
Barnstead/Thermolyne Lab-Line Environmental Chambers
Cuvette
containing
sample
Spectrophotometer
Spectronic 20+/20D+ Spectrophotometers
Gilson Pipetman P