“In theory, reality and theory are the

same. In reality, they are not.”

Metrology
Bob O’Brien
Dave Miller
NHCTC at Pease
 Welcome to the Eggsentrix
Annual Stockholder’s Meeting!
Our mission: To meet or exceed our
customer’s expectations for highest
quality extra large eggs.

Al Bumen, CEO
Eggsentrix Inc.
 The News
$

• Production costs up 48% Yield

• Extra Large egg yield down by 65%

• However, medium and small egg

production up by 65% offsets some losses

• Customer satisfaction is up!

 Our Process
• Raise top quality laying hens
• Collect eggs with a
computerized egg handling
system to ensure the
freshest eggs
• Classify eggs according to
weight to assure consistency
of extra large eggs
• Package eggs in protective
containers
• Listen to our customers!
 Customer Feedback!
• “I used to use three eggs in my omelets,
but with Eggsentrix eggs, two are plenty!”
N. E. Juan
• “Eggsentrix eggs are the first and last
things I can place in my shopping basket!”
R. U. Serius
• “Two dozen Eggsentrix eggs feed my
family of four for a week!” I.C. Yu
 Recent Production Solutions
• Intensive selection of breeding stock to develop
hens that lay extra large eggs
• Development of specialized high yield feed
• Utilization of custom packaging to handle the
improved egg requirements
• Continued engineering to find
solutions to producing extra
large eggs!
What do you think is the real problem?

• Are the eggs getting smaller?

• Are the engineering methods effective?
• What is the real issue?

80 80

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
of the calibration system
must be done in a
methodical and
documented manner
• The changes must be
evaluated and approved by
all stakeholders including
users, Engineering, Quality
Assurance, and Process
Owner.
User requests change
Engineering defines detail
QA approves change
Change maker
documents change
Process
Owner/Engineering/QA
signs-off change &
document archived
 Documentation
• Documentation standards must be
followed:
– Master document file
– Approval procedures
– Change procedures
– Version control
– Distribution control
– Assure only current documents are deployed
 Electronic Records
• Management of electronic records for
“paperless” calibration operations
• FDA 21 CFR Part 11 standard for
electronic records, electronic signatures,
and time stamps
• Key concepts: validation, audit trail, copies
of records, record retention
 Auditing
• Periodic audits assure that the calibration
plan is being followed
• Provides an opportunity to implement
corrective action
• Formal audit report documents audit
process
 Calibration Management Software
• Commercial software packages are available to:
– Automate calibration management tasks
– Assure compliance with standards organizations
– Comply with FDA 21 CFR Part 11 electronic
signatures
– Maintain documentation and instrument records
– Trace standards used in calibration
– Track changes with audit trail
– Support “paperless” calibration management
– Generate reports
 EXAMPLE
CALIBRATION
MANAGEMENT
SYSTEM
 Calibration Management
Technician
• Responsible for responding to calibration
needs
• Perform calibration procedures
• Document calibration operations
• Handle out-of-calibration conditions
• Perform TQM tasks
Example of a Traceability
Certification
Example Calibration Work Form
Equipment Log Book
Example Calibration SOP
Example Calibration Label
 STANDARDS
ORGANIZATIONS
 Standards Organizations
• ISO - International Origination for Standardization
• ANSI - American National Standards Institute
• NIST - National Institute for Standards and Technology
• ASTM - American Society for Testing and Materials
• CLSI (formerly NCCLS) - Clinical and Laboratory
Standards Institute
• US EPA – US Environmental Protection Agency
• AOAC - Association of Analytical Communities
• UPC - United States Pharmacopeia
 ISO
• ISO International Origination for Standardization:
worldwide federation of national standards
bodies from 156 different countries that
promotes the development of standards and
related activities in the world with a view to
facilitating the international exchange of goods
and services.
• Developing by consensus international
standards including the ISO 9000 quality series
Publishing and updating the SI metric systems of
units.
 ANSI
• ANSI the American National Standards
Institute : administrator and coordinator of
the united States private sector voluntary
standardization system. ANSI does not
itself develop American National
Standards : rather it facilities their
development by establishing consensus
among qualified groups . ANSI is the sole
U.S representatives to ISO.
 NIST
• NIST the National Institute for Standards
and Technology : A U.S. federal agency
that works with industry and government
to advance measurement science and
development standards. Examples of
measurement –related services provided
by NIST.
 ASTM
• ASTM, the American Society for Testing
and Materials : coordinates efforts by
manufacturers , consumers , and
representatives of government and
academia to develop by consensus
standards of materials , products,
systems, and services. Examples of
measurement –related services provided
by ASTM are:
 CLSI
• CLSI: (formerly NCCLS) :The Clinical and
Laboratory Standards Institute (CLSI) is a global,
nonprofit, standards-developing organization
that promotes the development and use of
voluntary consensus standards and guidelines
within the healthcare community.
• Recognized worldwide for the application of a
unique consensus process.
• CLSI is based on the principle that consensus is
an efficient and cost-effective way to improve
patient testing and services.
 U.S. EPA
• EPA employs 18,000 people across the country,
including our headquarters offices in
Washington, DC, 10 regional offices, and more
than a dozen labs. Our staff are highly educated
and technically trained; more than half are
engineers, scientists, and policy analysts. In
addition, a large number of employees are legal,
public affairs, financial, information management
and computer specialists. EPA is led by the
Administrator, who is appointed by the President
of the United States.
 AOAC
• As the "Association of Analytical Communities,"
AOAC INTERNATIONAL is committed to be a
proactive, worldwide provider and facilitator in
the development, use, and harmonization of
validated analytical methods and laboratory
quality assurance programs and services. AOAC
also serves as the primary resource for timely
knowledge exchange, networking, and high-
quality laboratory information for its members.
 AOAC International Checklist
• Do you have an independent quality assurance
department? Is your lab accredited with any
organization? If so, which one(s)? Do you follow any
published standard of good laboratory practices?
• What information can I provide that will be helpful in the
analysis of my product?
• Will any of the sample testing be outsourced to another
lab?
• Please describe how you handle samples from the time
of receipt, through lab analysis, report issuance, and
data archiving.
• Do you have written procedures and schedules for
instrument and equipment maintenance and calibration?
If so, how can you substantiate this?
 AOAC International Checklist
• Do written valid test methods exist for the sample
analysis? How do you assure that the test result(s) is
both accurate and precise?
• How much experience does your lab, and the analyst
working on the sample, have in dealing with this analyte
and matrix?
• Do you record raw data in bound books (laboratory
notebooks) or in other laboratory information systems? Is
there a way to track a final report to the original raw
data? What is the time period for retaining raw data and
will you provide such data upon request?
• Based on your experience with this test/matrix and the
current lab workload, do you anticipate on-time delivery
of the results?
• What policies and procedures do you follow to assure
that those results are valid?
 USP
• The United States
Pharmacopeia–National
Formulary (USP–NF) is a
book of public
pharmacopeial standards.
It contains standards for
medicines, dosage forms,
drug substances,
excipients, medical
devices, and dietary
supplements.
 References
• ISPE “GAMP Good Practice Guide, Calibration
Management”
• “Rules and Guidance for Pharmaceutical Manufacturers
and Distributors,” MCA, 1997
• US Code of Federal Regulations, Title 21, Food and
Drugs
– 21 CFR Part 211 – “Current Good Manufacturing Practice for
Finished Pharmaceuticals”
– 21 CFR Part 11 – “Electronic Records, Electronic Signatures”
• Federal Standard 209E, “Airborne Particulate
Cleanliness Classes in Clean Rooms and Clean Zones,”
1992, Institute of Environmental Science
Kaye SOP for valprobe system
Kaye Validation/ Calibration
Equipment Supplier
 CALIBRATION
PHYSICS AND
INSTRUMENTS
 Calibration physics and Example
Instruments
• Temperature • Aseptic
• Pressure • Fluid flow
• Weight/mass • Humidity
• pH • Optical
• RPM • Time
• Electrical • Volume
 The buzz words (1)
• Data : Raw figures that are gathered
• Information: knowledge that is extracted from data
• Qualitative: data that is purely descriptive
• Quantitative: magnitude or intensity of a physical phenomenon
• Empirical data: values recorded directly from an experiment or
observation
• Processed data that has been analyzed
• Analysis is the process of explaining results
• Error is the difference between the true or best to be accurate if the
error is small
• Systematic: consistently appear in measurement in the same
direction factors to look at : contaminated solution, malfunctioning
instrument, and environmental inconsistencies.
• Random: tend to vary in both directions from the true value,
extremely or impossible to find and eliminate .
 The buzz words (2)
• Gross errors : human mistakes
• Accuracy refers to the comparison of the measured and accepted ,
or true value
• Precision is a measure of the repeatability of a series of data points
taken in the measure of some quantity, both resolution and stability
• Stability freedom form random variations in the results
• Repeatability is the precision of measurements made under uniform
conditions repeated in successions..
• Reproducibility is the precision of measurements made under non-
uniformed conditions , such as different locations.
• Performance verification : is a process of checking that an
instrument is performing properly.
• Validation( instrument): is a comprehensive set of test done before
an instrument is put into service that demonstrate that it will work
within specified parameters and in the conditions under which it will
operate.
• Preventative maintence: is a program of scheduled inspections of
instruments and the equipment that leads to minor adjustments and
ensures that proper function of equipment or instruments.
 Measurement
• If a parameter is not Simplified Measurement System
measured, it cannot be
Physical
controlled Transducer Quantity
• Measurement: is the
process of association a Transmission path
number with a quantity by Conditioning
Signal
comparing the quantity to
a standard.
• Characterized by the Processing Signal
sensitivity, dynamic
range, and resolution of
the measurement. Displayed Information
interpretable by human or computer
 Statistics

• Method for handling data and X = X1+X2+X3+… +Xn

drawing conclusions n
• Descriptive stats: deal with the
collection processing and
analysis of data to make it
comprehensive. % Error= True Value- Measured
• Statistical inference goal is the Value(100%) /True Value
interpretation of the data and
drawing conclusions.
• Frequency distribution number
of occurrences for which
measurement that lie with in
some interval
• Normal distribution error that is
strictly random
 PM
• Ensure correct results are capable of being
obtained
• Identify weakened components that require
replacement to maintain proper functioning.
• Ensure instruments are safe to operate
• Ensure that failing instrument will not result in
major shut down or out of specification issue
• Lower cost of repairs
Lockout/Tagout
 Aseptic Practices
• Used while performing calibration to avoid
inadvertently cross-contaminating:
– Biological pharmaceutical products
– Buffers
– Tools
– Supplies
 Transducers
• Sensor selection is dependent on: measurement range
required to perform, environmental conditions operated
in
• Conversation of a physical parameter into an electrical
quantity:
• Temperature, heat, stress, strain, pressure,
displacement, velocity, and acceleration
• Load cell: measures a force indirectly by deformation
produced in a beam or other structure. The deformation
is converted to a resistance change by a strain gauge
that is bond ed to the surface of the beam.
• Resistive transduction can be used to measure light and
temperature. Constructed from platinum and their
resistance increases as temperature increases.
 Traceability
• Traceability describes the chain of calibrations that
establishes the value of a standard or of a
measurement.
• In the U.S. traceability for physical and some chemical
standards is often to NIST since NIST maintains
primary standards.
• Uncertainty of the standard used for calibration
Intervals is dependent on various factors accuracy and
confidence level , daily usage, predicted or actual drift
performance check or verification .
 Basic Principles of Weight
Measurement
• Weight is the force of gravity on an object.
• Balances are instruments used to
measure this force.
• Balance Range
• Balance Capacity
• Balance Sensitivity
• Mechanical
• Electronics
 Weight vs. Mass
• Mass is the resistance of an object to a change
in its motion, while weight is the gravitational
force of attraction between the object and the
Earth. Mass and weight even have different
units. Nonetheless, the terms weight and mass
are sometimes used interchangeably.
• Weight = force of attraction between the Earth
and an object = mass * acceleration due to
gravity
• Mass = Mass is the amount of matter in an
object
 Basic Procedures for Weight
Measurement
• Make sure balance is level
• Adjust balance to zero
• Make sure the weight plan is clean and empty
and chamber doors are in the closed position
• Tare the weight container
• Place the sample into the weighing pan and read
the value for the measurement
• Remove the sample
• Clean the balance and area around it
Balance Basics

• The sample placed onto a

balance weight boat on the
pan pushes the pan down with
a force equal to m g, where m
is the mass of the object and g
is the acceleration of gravity.
• An electronic balance uses
electromagnetic force to return
the pan to its original position.
3. Electric current required to
generate the force is
proportional to the mass,
which is displayed on a digital
readout on the balance.
 Electronic Balance
Ohaus Scout Pro Balance

Internal overload protection

ensures safety from damage
caused by excessive weight
Sudden impact protection
eliminates the worry of dropping or
being unexpectedly struck
Multiple weighing units and built-in
application modes
Built-in calibration procedures
 Balance Scale (Triple Beam)
Ohaus Triple Beam Balances

Precision-cast poises and deep

notchs in beams for accurate
values every time
Precision-ground knife edges and
self-aligning agate bearings provide
maximum sensitivity and
reproducibility
Response time is quick and
accurate
Magnetic dampening minimizes
oscillation
Tare beam allows containers up to
225g to be balanced out
 Autoclaves
• Autoclaves have instrumentation and
control packages varying from relay
controlled with simple pressure and
vacuum gauges and a chart recorder to
microprocessor controlled systems with full
SCADA2 functionality.
• Replace all of the air in contact with the
load to be sterilized with steam of the right
quality and of the right temperature and
pressure for the correct length of time.
• The critical parameters are steam quality,
temperature and time.
• The critical calibrations are temperature,
pressure and time.
 Calibration of an Autoclave
• Temperature calibration
• Thermocouple is placed
into chamber to allow
same source location for
both thermocouples
• Correlation between the
temperature gauge on
instrument and gage on
autoclave
 Autoclave
Tuttnauer Autoclaves

An autoclave is a device that uses

heat to sterilize equipment and other
objects. This process inactivates all
bacteria, viruses, fungi, and spores.
Features slow and fast exhaust for
steam sterilization of liquids, media,
instruments and glassware
Self-contained design with refillable
reservoir allows control of the water
purity for sterilization
Drying cycle removes residual
moisture after sterilization
Temperature range: 100° to 134°C
(212° to 273°F)
 pH
pH is a unit of measurement which describes the degree of
acidity or alkalinity of a solution. pH refers to a combination
of p for power and H for the symbol of the element
hydrogen. pH is defined in chemistry as the negative log of
the activity of the hydrogen ion:
pH=-log10H+
pH is a measurement of the activity of hydrogen ions in a
solution at a given temperature. Activity is a function of the
availability of hydrogen ions and not their concentration in a
solution. pH is measured on a scale of 0 to 14 where pH
values less than 7 are considered acidic and values greater
than 7 are alkaline.
pH of Common Substances
pH Value Compound
0.3 Sulfuric acid
3 Wines
5-6 Purified laboratory water
5 Pure water
6 Sea water
8.4 Sodium bicarbonate
12.6 Bleach
14 1 M Sodium Hydroxide
 pH Meter
Oakton pHTestr 2

Compact, portable pH meter.

Features of this meter include one-
piece body design, microprocessor
control with digital display, and
automatic temperature control
(ATC).
 pH Meter Calibration (1)
Calibration
PH meters must be calibrated properly and
regularly to provide accurate readings. The
OAKTON pHTestr 2 uses up to three-point
calibration (pH 4, 7,and 10) and
automatically recognizes the selected buffer.

1. Turn the instrument on using the

ON/OFF button.
2. Dip the electrode end of the unit into the
selected buffer (pH 4, 7, or 10) up to the
color band. Immersing the unit deeper into
the test solution could damage electronic
components in the instrument.
 pH Meter Calibration (2)
Calibration (cont’d)
3. Press the CAL button. The instrument is in calibration mode and “CA”
will appear on the display. Calibration begins when a number close to the
selected buffer starts to flash on the display.
4. After about 30 seconds confirm calibration by pressing the HOLD/CON
button. If calibration is confirmed, “CO” will appear on the display. The
buffer value reading will then be shown on the display.
5. The procedures listed in steps 2-4 are then repeated using the other
two buffers, if desired.
6. Periodically check the calibration of the instrument to verify proper
operation. Full calibration of the instrument should be performed daily.
Confirmation of calibration with a known buffer solution should be
performed before, and after the measurement of a set of samples.
 Temperature
• In a qualitative manner, we can describe the temperature of an
object as that which determines the sensation of warmth or
coldness felt from contact with it.
• When the thermal changes have stopped, we say that the two
objects (physicists define them more rigorously as systems) are in
thermal equilibrium . We can then define the temperature of the
system by saying that the temperature is that quantity which is the
same for both systems when they are in thermal equilibrium.
• Celsius is more widely used that the Fahrenheit scale. Freezing
point for water is 00 and boiling point is 1000 Celsius

° 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

Real-time datalogging with infrared output to

transfer data to your computer. Logs up to 1000
readings in one second to 60-minute intervals.
Thermometer measures minimum, maximum
and differential readings using one to two
probes. UL listed intrinsically safe for use in
Class I; Groups A, B, C, and D Division 1
hazardous locations. Thermometer is also
available with NIST certification
 Thermometer
Fisherbrand* Factory-Calibrated Thermometers

Total immersion. Use to verify and

calibrate routinely used
thermometers including Liquid-In-
Glass, RTD's, Thermistors,
Thermocouples and Bi-Metal
thermometers. Each thermometer is
certified at points listed below.
Calibrated to meet the requirements
of ISO/EC Guide 25, ANSI/NCSL
2540-1-1994, ISO 9000/QS 9000
Series of Quality Standards, and
MIL STD 45662A.
Supplied with documentation to
prove traceability to NIST.
 Temperature Calibration Meter
Omega CL20 High Precision Handheld Meter, Calibrator / Thermometer,
Thermocouples, RTD's and Thermistors

Simulate, measure and record RTD, ohm,

thermocouple and thermistor signals–all in one
meter. 0.3°C 0.5°F accuracy and in ambient
temperatures from 18 to 28°C 64 to 82°F).
Conform to the temperature/voltage tables of
the National Institute of Standards and
Technology (N.I.S.T.). OMEGA provides a free
NIST Traceable Certificate of Calibration for
your records.
 Pyrometer
Barnstead* Handheld Digital Pyrometer

Measures temperature of solids, liquids or

gases. Ambient operating temperature
limits: 0–50°C.
•Can be calibrated to NIST standards
•Type K readout range: -200 to
+1372°C/-328 to +2502°F; Type J: -200 to
+1000°C/-328 to +1832°F
 RTD
Digi-Sense* ThermoLogR* RTD Thermometers

Perfect for on-site documentation. Infrared output

allows data transfer to your computer via the
optional RS-232 adapter. Simultaneously monitor
current, minimum, and maximum readings.
CAL button enables you to field calibrate the meter.
°F/°C selectable range is -330 to +2210°F (-201 to
+1210°C). Resolution is 0.01°F/°C from -99.99 to
99.99°F/°C; 0.1°F/°C from -100.0 to -330°F/°C and
from 100.0 to 999.9°F/°C; and 1°F/°C above
1000°F/°C.
Accuracy is ±0.06°F (±0.03°C) from -99.99 to
99.99°F/°C; ±0.1°F/°C from -100.0 to -330°F/°C
and 100.0 to 999.9°F/°C; ±1°F/°C above 1000°F/
°C. Use probes (not included) with round, 3-pin
locking connector.
 Freezers, Refrigerators
Fisher Isotemp* General-Purpose Refrigerator/Freezer

Capacity: 17.9 cu. ft. (507L) (refrigerator, 12.9 cu. ft.

[365L]; freezer, 5.0 cu. ft. [142L])
Temperature range from 2° to 13°C (refrigerator), -18°
to -10°C (freezer)
CFC-free R-134a refrigerant
Manual or automatic defrost
Yellow warning label reads: "Laboratory Refrigerator"
Separate adjustment of refrigerator and freezer
temperatures
 Furnace
Thermolyne Muffle Furnaces

These laboratory muffle furnaces are

ideal for the determination of volatile and
suspended solids, drying and
evaporating, ignition tests, gravimetric
analysis, ashing organic and inorganic
samples, and heat treatment operations.
Stepless input controller holds any
temperature from 100° to 1100°C. Direct
reading pyrometer has °C and °F scales.
All models are compensated for room
temperature variations and molded with
ceramic fiber insulation, offering excellent
chemical stability and resistance to
corrosive agents
 Depyrogenation Oven
HF4-2 SHEL LAB High Performance Oven

Designed for continuous drying operations at

temperatures up to 300°C. Factory-set over-
temperature protection prevents control
failure from damaging contents and guards
against burnout. The temperature controller
provides 24-step ramp and soak, 0.1°C
control, multiple levels of operator access
and automatic resumption of program
following a power failure. Time and
temperature are displayed in three-digit LED
readout for fast and accurate setting.
 Hot plate
Cimarec Digital Hotplates and Stirring Hotplates

LED indicates temperature settings, adjustable

in 5° increments, from 5° up to 550°C (41° to
1022°F)
Microprocessor-controlled feedback
technology maintains consistent, repeatable
temperature settings
CSA approved
Stirring models
Microprocessor feedback control provides
constant speed regardless of changes in
viscosity and prevents runaway and magnetic
decoupling
Stirring speed ranges from 60 to 1200rpm
 Incubator
Lab-Line Incubators

These incubators were specifically

designed to meet the requirements of
clinical and teaching laboratories. The
educational model (not for clinical use) is
designed for microbiological and
biochemical studies.
•Feature adjustable bimetallic thermostat
control
•Front light indicates when heaters are
active
 Pressure Calibration Meter
Omega DPI603 Pressure Calibrators

Enables pressure instrumentation to be

serviced in remote locations. Features a
built-in pump to generate pressures up to
300 psi. An optional pressure/ vacuum
pump enables the hand pump to source
pressure or vacuum down to 22 inHg. In
addition to the pressure/vacuum
measurement, can also measure voltage or
current up to ± 50 Vdc or ± 55 mA dc.
 Pressure measurement
• Each a square meter of the bottom area carries the same weight as
every other square meter, force per unit area is defined as pressure.
• P=F/A
• P= pressure n/m2(Pa)
• F= force , N
• A+ area, m2
• newtons per square meter = pascal (Pa)
• Pounds per square inch (PSI)
• Gage pressure (PSIG): reading difference between the atmospheric
pressure. pressure readings that including the atmospheric
contribution are called absolute pressures (PSIA);
• Differential pressure :is the difference between two pressures
 Electrical Terminology
• Analog signals or digital signals
• Alternating current AC: electrical current that cycle between flowing first in on
direction and then in the other direction.
• Current: the flow of charge , may involve the movement of electrons in a
conductor or ions in a solution.
• Direct current: current that always flows in the same direction.
• Discrete time signals
• Current
• Analog to Digital converters: device that converts analog to digital values.
• Frequency : the rate at which alternating current cycles back and forth,
measured in cycles / sec usually referred to as Hertz = 1Hz /1 cycle second.
• Polarity: the characteristic of having a positive or negative charge.
• Transformer: a device used to change AC voltages.
• Signal: an electrical change that conveys information. For example, a change
in voltage, current, or resistance.
• Noise (electrical) Unwanted electrical interference which corrupts a signal.
• Watts, W: unit of power .
 Commonly Measured Electrical
Parameters
• Electromotive force (Volts = Amps * Ohms)
• Current (Amps = Volts / Ohms)
• Resistance (Ohms = Volts / Amps)
• Conductivity (Siemens = 1 / Ohms)
• Capacitance and Inductance (The passive ability
to store or release electrical energy in a circuit.
Measured in units of Farads and Henrys
respectively)
• Frequency (Cycles per second of a time-varying
signal)
 VOM (Volt Ohm Meter)
Digital Multimeter DMM
• Typically capable of measuring:

– AC voltage: Select an appropriate range higher than expected.

Values displayed id the RMS value
– DC Voltage :Select an appropriate range higher than expected
– AC current: typically requires movement of probe leads into
appropriate jacks along with appropriate range higher than
expected. Meter must be connected in series with the electrical
circuit under test. Values displayed id the RMS value
– DC current: typically requires movement of probe leads into
appropriate jacks along with appropriate range higher than
expected
– Ohms: the zero adjust should be verified at each use referred to
as confidence test
– Some meters will also measure other parameters such as
temperature, frequency, or capacitance
 Digital Multimeter
Fluke 189 Data Logging Multimeter

The Multimeter and Software Combo

Pack provides a practical, affordable
approach to achieve significantly
improved maintenance performance
with the flexibility to monitor more than
20 different electrical functions plus
temperature.
 Conductivity
Oakton Waterproof TDS/Conductivity Meters

Microprocessor-controlled TDS or
conductivity testers offer field durability, plus
±1% full-scale accuracy
Automatic temperature compensation over
the entire 0° to 50°C (32° to 122°F) 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

Feature precise microprocessor-based PID

control, an operating temperature range of
10° above ambient to 60°C, temperature
control and uniformity of ±0.5°C, spray
nozzles for humidification.
Refrigeration system has a temperature
range of 5° to 60°C for working at or below
room temperature. Dehumidification feature
maintains humidity at or below ambient
conditions with ±5% humidity control. 10 in.
(25.4cm), seven-day, two-pen chart recorder
creates a permanent record of temperature
and humidity.
 Flow gage
Gilmont* Industrial Correlated Aluminum Flowmeter

Provides liquid or gas flow readings at capacity

levels to 0.48gpm of water while maintaining an
accuracy of ±5% of full scale. Includes calibration
table for air and water. Certificate indicating
instrument traceability to standards provided by
NIST available on request.
 Manometer
Princo Bench Model Manometer

Enclosed in glass jacket, with 5 in.

diameter (12.7cm) metal base and 1/4 in.
(0.6cm) nipple connections. Inner tube is
filled with mercury and open to chamber.
Scale is graduated upward and downward
from center zero (1mm divisions). Absolute
pressure is sum of readings for both
columns. Constriction in manometer
checks mercury surge if the vacuum is
broken suddenly.
 Fume hood
Fisher Hamilton PaceAire Fume Hood

Constant volume/bypass airflow system

efficiently removes fumes and vapors
while keeping the airflow and duct
velocity constant. Two-speed integral
blower allows the fume hood to operate
at a lower mode to conserve energy and
offers face velocity adjustment to
coordinate with a wide range of duct
conditions. Low-speed blower exhaust,
0.11sp at 75fpm face velocity (492cfm)
high-speed blower exhaust, 0.28sp at
100fpm face velocity (657cfm).
 Biological Safety Cabinet
Esco Infinity Class II Type A2 Biosafety Cabinet

Pending GS certification to EN 12469

Product / Operator / Environment
Protection
ULPA Filters with typical efficiency at
>99.999% at 0.12μm provide ISO Class
3 cleanliness within work zone.
HPV-compliant for safe decontamination
using BIOQUELL’s technology
Isocide™ antimicrobial coated structure
eliminates 99.9% of bacterial presence
on external surfaces within 24 hours.
Redundant fans
 Humidity
Fisherbrand Digital Humidity/Temperature Meter

Displays relative humidity from 10.0 to 95.0%

with a resolution of 0.1% and an accuracy of
1.5%
Temperature range is -40.0° to +104.4°C
(-40.0° to +220.0°F) with a resolution of 0.1°
and an accuracy of ±0.2°C (±0.4°F)
Dew point range is -40.0° to +60.0°C (-40.0° to
+140.0°F)
An ISO 17025 certificate is provided to indicate
instrument traceability to standards provided
by NIST
 IR Thermometer
Fluke 572 Noncontact Infrared Thermometers

Highly advanced portable IR thermometer reads

surface temperatures at a distance.
Broad temperature range of -30° to +900°C
(-25° to +1600°F)
Certifications: Available with a NIST DKD
Calibration Certificate assuring its accuracy and
indicating instrument traceability to standards
provided by the National Institute of Standards
and Technology (NIST).
 Microscope
University Series Microscopes

This microscope series combines

advanced features with superior optics.
The Kohler illumination with field
diaphragm helps to maximize
resolution.
Features and Specifications
• The Seidentopf binocular head design
provides superior optical performance
• Calibration procedures for cleaning
and maintenance
• Objectives are available as standard
Achromats, or Plan Achromats.
 Spectrophotometers
• An instrument that measures
concentration on the basis of
the ability to absorb light in
direct proportion to their
concentration. Visible light
occurs in a very narrow band
of wavelengths approximately
400nm to 700nm.
• Spectrophotometers that are
designed for filters of colored
glass are called colorimeters.
 Spectrophotometer

Wavelength Meter / Display

Photo detector
selector

Cuvette
containing
sample
 Spectrophotometer
Spectronic 20+/20D+ Spectrophotometers

Single-beam units are suitable for general

colorimetric and spectrophotometric
applications
A detector covers the entire 340 to 950nm
wavelength range, extending measurements
into the near infrared and ultraviolet ranges
Simple filter selection lever makes changing
filters easy
Automatically calculate standard curves by
inserting sample and reading concentration
When standard is unavailable, manually
input the factor
 Timers
Traceable Lab Controller and Timer

Three-channel alarm timer features clock;

three timing alarms; audible and visual
alarms; manual OFF; metric converter;
calculator; repeat channel, memory channel,
and stopwatch channel.
Programmable for up to 224 ON/OFF
switchings per day and 1568 per week
Cycles equipment ON/OFF at any interval
from 100 hours to one second
Quartz crystal accuracy
Supplied with serial-numbered certificate
from an A2LA accredited ISO 17025
calibration laboratory to indicate traceability
to standards provided by NIST.
 Viscosity
Haake VT02 Rotational ViscoTester Viscometer

Speed-stabilized, rotor-driven motor measures the

torque produced by the measured liquid, which
directly correlates to viscosity. A scale indicates
the deflection of the measuring spring. Calibrated
for Newtonian substances, instruments indicate
data in units of dPas. Typical testing time is only 1
min. Sample temperature range is up to 150°C
(302°F). Rotational speed: 62.5rpm;
reproducibility: ±2 full scale; comparability: ±7 full
scale.
 Pipette

Gilson Pipetman P

Individually calibrated ... a Performance

Check Report is included with each
Pipetman, along with an engraved
Identification Number for traceability
• Tip holder and tip ejector are fully
autoclavable to avoid cross-
contamination
• P2 and P10 models are ideal for
molecular biology techniques (PCR, DNA
sequencing, etc.). Accurate and precise:
P10 down to 1 µL and P2 down to 0.2 µL
(0.1 µL with a good pipetting technique)
 Tachometer
Traceable Digital Tachometers

Use the touchless sensor to get speed

readouts in rpm, contact sensor for direct
readout of surface speeds in feet per
minute or meters per minute
Detects speeds from 1 to 99,999rpm from
a distance of 2 to 12 in. (5.1 to 30cm);
resolution is 0.1 below 1000, and 1 above
1000
Contact sensor provides readouts from 1
to 19,999rpm, 0.05 to 1999.9m/min. or 0.2
to 6560 ft./min; accuracy, 0.05%
ISO-17025 certificate is provided to
indicate instrument traceability to
standards provided by NIST
 Centrifuge
Eppendorf Models 5415D/5415R Microcentrifuges

Capacity: 48mL (24 x 1.5/2.0mL)

Maximum speed/force:
13,200rpm/16,110xG
Digital display for time and speed (rpm or
rcf); 5417R also displays temperature
Timed-run (30 seconds to 99 minutes),
adjustable short-spin and continuous-run
modes
Variable speed control to maximum in
200rpm increments
Quick acceleration and deceleration
 LABS
• Scout Pro Balance Scale Calibration
– Utilize internal calibration functions to zero
set, span, and linear calibrate a Scout Pro.
• Autoclave Validation BT Sure Biological
Indicator
– Utilize a biological indicator to validate proper
operation of an autoclave
 Lab Procedures
• Review other documents operation SOP,
maintenance SOP, calibration SOP (go
over reasons for each, equipment intro)
• Procedures generate work form
• Fill out work form (calibration form 1)
• Follow calibration SOP
• File work form
• Fill out and attach calibration stickers
Scout Pro Work Form (1)
Scout Pro Work Form (2)
Scout Pro Calibration SOP (1)
Scout Pro Calibration SOP (2)
Scout Pro Calibration SOP (3)
Scout Pro Calibration SOP (4)
Scout Pro Calibration SOP (5)
Scout Pro Calibration SOP (6)
 Calibration of an Autoclave
• Temperature calibration
• Thermocouple is placed
into chamber to allow
same source location for
both thermocouples
• Correlation between the
temperature gauge on
instrument and gage on
autoclave
 Autoclave Validation
Biological Indicator Strips
QC Microbiology
BT Sure SOP (1)
BT Sure SOP (2)
BT Sure SOP (3)
BT Sure SOP (4)
BT Sure SOP (5)
 Comments/suggestions?
• Review sheet
• Any input welcome!