Metrology

1
Metrology
In theory, reality and theory are the same. In
reality, they are not.

• Bob OBrien
• Dave Miller
• NHCTC at Pease

2
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.

3
The News

• Production costs up 48
• Extra Large egg yield down by 65
• However, medium and small egg production up by
  65 offsets some losses
• Customer satisfaction is up!

Yield
4
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!

5
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

6
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!

7
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
8
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!

9
What Should Be Done?

• ????

10
System approach

• Monitor/verify
• Periodic maintenance
• Periodic calibration
• Scheduling
• SOP
• Documentation
• QA
• Traceability

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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

12
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.

13
PRINCIPLES OF A CALIBRATION MANAGEMENT SYSTEM
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Calibration Management System (CMS)

• Essential elements
• Trained personnel
• Instrumentation assessment
• Management
• Documentation
• Corrective action procedures

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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

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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?

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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.

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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

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Establishing a Calibration Management System

• Criticality assessment
• Life cycle phases
• Project
• Pre-Operational
• Operational
• Training
• Change control
• Documentation
• Electronic Records
• Auditing

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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

21
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.

22
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

23
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.

24
Documentation

• Documentation standards must be followed
• Master document file
• Approval procedures
• Change procedures
• Version control
• Distribution control
• Assure only current documents are deployed

25
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

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Auditing

• Periodic audits assure that the calibration plan
  is being followed
• Provides an opportunity to implement corrective
  action
• Formal audit report documents audit process

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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

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EXAMPLE CALIBRATION MANAGEMENT SYSTEM
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Calibration Management Technician

• Responsible for responding to calibration needs
• Perform calibration procedures
• Document calibration operations
• Handle out-of-calibration conditions
• Perform TQM tasks

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Example of a Traceability Certification
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Example Calibration Work Form
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Equipment Log Book
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Example Calibration SOP
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Example Calibration Label
35
STANDARDS ORGANIZATIONS
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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

37
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.

38
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.

39
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.

40
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

41
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.

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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.

43
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.

44
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?

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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?

46
USP

• The United States PharmacopeiaNational Formulary
  (USPNF) is a book of public pharmacopeial
  standards. It contains standards for medicines,
  dosage forms, drug substances, excipients,
  medical devices, and dietary supplements.

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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

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Kaye SOP for valprobe system
49
Kaye Validation/ Calibration Equipment Supplier
50
CALIBRATION PHYSICS AND INSTRUMENTS
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Calibration physics and Example Instruments

• Aseptic
• Fluid flow
• Humidity
• Optical
• Time
• Volume

• Temperature
• Pressure
• Weight/mass
• pH
• RPM
• Electrical

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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 .

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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.

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Measurement

• If a parameter is not measured, it cannot be
  controlled
• Measurement is the process of association a
  number with a quantity by comparing the quantity
  to a standard.
• Characterized by the sensitivity, dynamic range,
  and resolution of the measurement.

Simplified Measurement System
Physical Quantity
Transducer
Transmission path
Conditioning Signal
Processing Signal
Displayed Information interpretable by human or
computer
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Statistics

• Method for handling data and drawing conclusions
• Descriptive stats deal with the collection
  processing and analysis of data to make it
  comprehensive.
• Statistical inference goal is the 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

• X X1X2X3 Xn
• n
• Error True Value- Measured Value(100) /True
  Value

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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

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Lockout/Tagout
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Aseptic Practices

• Used while performing calibration to avoid
  inadvertently cross-contaminating
• Biological pharmaceutical products
• Buffers
• Tools
• Supplies

59
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.

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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 .

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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

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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

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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

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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.

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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
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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
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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.

68
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

69
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 134C
(212 to 273F)
70
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.
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pH of Common Substances

• pH Value Compound
• 0.3 Sulfuric acid
• Wines
• 5-6 Purified laboratory water
• Pure water
• Sea water
• 8.4 Sodium bicarbonate
• 12.6 Bleach
• 14 1 M Sodium Hydroxide

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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).
73
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.
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pH Meter Calibration (2)
Calibration (contd) 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.
75
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

76
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.

77
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.

78
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.

79
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
80
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.
81
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 signalsall in one
meter. 0.3C 0.5F accuracy and in ambient
temperatures from 18 to 28C 64 to 82F). 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.
82
Pyrometer
Barnstead Handheld Digital Pyrometer
Measures temperature of solids, liquids or gases.
Ambient operating temperature limits 050C.
Can be calibrated to NIST standards Type K
readout range -200 to 1372C/-328 to 2502F
Type J -200 to 1000C/-328 to 1832F
83
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 2210F
(-201 to 1210C). Resolution is 0.01F/C from
-99.99 to 99.99F/C 0.1F/C from -100.0 to
-330F/C and from 100.0 to 999.9F/C and
1F/C above 1000F/C. Accuracy is 0.06F
(0.03C) from -99.99 to 99.99F/C 0.1F/C
from -100.0 to -330F/C and 100.0 to 999.9F/C
1F/C above 1000F/C. Use probes (not
included) with round, 3-pin locking connector.
84
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 13C
(refrigerator), -18 to -10C (freezer) CFC-free
R-134a refrigerant Manual or automatic
defrost Yellow warning label reads "Laboratory
Refrigerator" Separate adjustment of
refrigerator and freezer temperatures
85
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 1100C. 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
86
Depyrogenation Oven
HF4-2 SHEL LAB High Performance Oven
Designed for continuous drying operations at
temperatures up to 300C. Factory-set
over-temperature protection prevents control
failure from damaging contents and guards against
burnout. The temperature controller provides
24-step ramp and soak, 0.1C 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.
87
Hot plate
Cimarec Digital Hotplates and Stirring Hotplates
LED indicates temperature settings, adjustable in
5 increments, from 5 up to 550C (41 to
1022F) 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
88
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
89
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.
90
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.
• PF/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

91
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 .

92
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)

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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

94
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.
95
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 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
96
Environmental chamber
Barnstead/Thermolyne Lab-Line Environmental
Chambers
Feature precise microprocessor-based PID control,
an operating temperature range of 10 above
ambient to 60C, temperature control and
uniformity of 0.5C, spray nozzles for
humidification. Refrigeration system has a
temperature range of 5 to 60C 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.
97
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.
98
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.
99
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).
100
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 gt99.999 at 0.12µm
provide ISO Class 3 cleanliness within work zone.
HPV-compliant for safe decontamination using
BIOQUELLs technology Isocide antimicrobial
coated structure eliminates 99.9 of bacterial
presence on external surfaces within 24 hours.
Redundant fans
101
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 104.4C
(-40.0 to 220.0F) with a resolution of 0.1
and an accuracy of 0.2C (0.4F) Dew point
range is -40.0 to 60.0C (-40.0 to
140.0F) An ISO 17025 certificate is provided to
indicate instrument traceability to standards
provided by NIST
102
IR Thermometer
Fluke 572 Noncontact Infrared Thermometers
Highly advanced portable IR thermometer reads
surface temperatures at a distance. Broad
temperature range of -30 to 900C (-25 to
1600F) 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).
103
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.
104
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.

105
Spectrophotometer
Meter / Display
Photo detector
Wavelength selector
Cuvette containing sample
106
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
107
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.
108
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 150C (302F). Rotational speed 62.5rpm
reproducibility 2 full scale comparability 7
full scale.
109
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)
110
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
111
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
112
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

113
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

114
Scout Pro Work Form (1)
115
Scout Pro Work Form (2)
116
Scout Pro Calibration SOP (1)
117
Scout Pro Calibration SOP (2)
118
Scout Pro Calibration SOP (3)
119
Scout Pro Calibration SOP (4)
120
Scout Pro Calibration SOP (5)
121
Scout Pro Calibration SOP (6)
122
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

123
Autoclave Validation
Biological Indicator Strips QC Microbiology
124
BT Sure SOP (1)
125
BT Sure SOP (2)
126
BT Sure SOP (3)
127
BT Sure SOP (4)
128
BT Sure SOP (5)
129
Comments/suggestions?

• Review sheet
• Any input welcome!