POTENTIAL SOURCES OF ELEMENTAL IMPURITIESMehulJain143
INTRODUCTION
INDENTIFICATION OF POTENTIAL ELEMENTAL IMPURITIES
FACTORS AFFECTING
EVALUATION
RISK ASSESSMENT AND CONTROL OF ELEMENTAL IMPURITIES
GENERAL PRINCIPLES
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
Our objective is to demonstrate how Total Organic Carbon (TOC) analysis is a quick, accurate screening alternative for critiquing cleaning validation samples.
Typical laboratory testing includes the development and implementation of analytical methods that test for residues of previously manufactured products, cleaning detergents, chemicals, solvents, byproducts, degradants, and microbial contaminates (from wet environments after the cleaning validation). TOC analysis has become one of a series of analytical methods used to assess the effectiveness of a cleaning validation. Almost any residual compound can be detected if three non-specific analytical (screening) tests are applied to a cleaning validation: TOC (for organics characteristics– carbon), pH (for acid/base characteristics) and conductivity (for ionic characteristics).
Analytical precision and analyte recovery for cleaning agents (detergents) and other possible contaminates that may be found in clean in place (CIP) solutions will be investigated for TOC. TOC analysis demonstrated equivalent or better correlation to cleaning validation compounds in comparison to traditional analytical methods. Some qualities that make TOC a viable part of a cleaning validation includes: high sensitivity, high recovery of samples, non-specific measurement, ease of use (little method development), minimal interferences and cost effectiveness.
This presentation will focus on the characteristics and benefits of TOC with general implementation guidelines for performing cleaning validation. By taking a proactive approach to one’s cleaning validation program, one can guarantee effective performance while minimizing downtime.
POTENTIAL SOURCES OF ELEMENTAL IMPURITIESMehulJain143
INTRODUCTION
INDENTIFICATION OF POTENTIAL ELEMENTAL IMPURITIES
FACTORS AFFECTING
EVALUATION
RISK ASSESSMENT AND CONTROL OF ELEMENTAL IMPURITIES
GENERAL PRINCIPLES
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
Our objective is to demonstrate how Total Organic Carbon (TOC) analysis is a quick, accurate screening alternative for critiquing cleaning validation samples.
Typical laboratory testing includes the development and implementation of analytical methods that test for residues of previously manufactured products, cleaning detergents, chemicals, solvents, byproducts, degradants, and microbial contaminates (from wet environments after the cleaning validation). TOC analysis has become one of a series of analytical methods used to assess the effectiveness of a cleaning validation. Almost any residual compound can be detected if three non-specific analytical (screening) tests are applied to a cleaning validation: TOC (for organics characteristics– carbon), pH (for acid/base characteristics) and conductivity (for ionic characteristics).
Analytical precision and analyte recovery for cleaning agents (detergents) and other possible contaminates that may be found in clean in place (CIP) solutions will be investigated for TOC. TOC analysis demonstrated equivalent or better correlation to cleaning validation compounds in comparison to traditional analytical methods. Some qualities that make TOC a viable part of a cleaning validation includes: high sensitivity, high recovery of samples, non-specific measurement, ease of use (little method development), minimal interferences and cost effectiveness.
This presentation will focus on the characteristics and benefits of TOC with general implementation guidelines for performing cleaning validation. By taking a proactive approach to one’s cleaning validation program, one can guarantee effective performance while minimizing downtime.
Considerations to Extractables and Leachables Testing SGS
How to organize Extractables Assessments? FDA continues to issue Warning Letters to companies that fail to properly complete Design Verification, Design Validation, and Process Validation, and recently to include failures of manufacturers in Risk Management. The evaluation of extractables and leachables has become an increasingly important aspect in the Quality by Design (QbD) initiative of the FDA in the area of drug product design, including materials used in the drug product production process and container and closure systems used for product packaging. This presentation provides general approaches and practical aspects in E&L testing.
Analysis of Raw materials…..
This topic comes under Quality Control and Quality Assurance…….
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in Fist year sem I......
This Presentation Contain following...
#Definition
#Purchase Specification
#GMP & WHO guidelines for handling of raw materials
#Control on Raw Materials
#Sampling of Raw Materials
#Raw Materials Testing
Thanks for Help and Guidance of Dr. F. A. Tamboli Sir and Dr.Mrs. N.M.Bhatia Madam
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
M. pharma quality assurance
role of quality system and audit in pharmaceutical manufacturing environment.
topics covered are as follows
cGMP regulation
quality assurance functions
quality system approach
management responsibility
resources
The personnel is the most important asset of a company, and the easiest to neglect. The establishment and maintenance of a satisfactory system of quality assurance and GMP relies upon people who develop the system, the people who use the system and the people who examine the system to see if it has worked.
The technical people must have a knowledge and understanding of GMP to enable them to carry out their duties in accordance with GMP. These people must have the level of training and experience that will enable them to do their professional works respectively.
Tektronix keithley Product and Application update Q2 2016Jeff Sable
Tektronix delivers innovative, precise and easy-to-operate test, measurement and monitoring solutions that solve problems, unlock insights and drive discovery.
Considerations to Extractables and Leachables Testing SGS
How to organize Extractables Assessments? FDA continues to issue Warning Letters to companies that fail to properly complete Design Verification, Design Validation, and Process Validation, and recently to include failures of manufacturers in Risk Management. The evaluation of extractables and leachables has become an increasingly important aspect in the Quality by Design (QbD) initiative of the FDA in the area of drug product design, including materials used in the drug product production process and container and closure systems used for product packaging. This presentation provides general approaches and practical aspects in E&L testing.
Analysis of Raw materials…..
This topic comes under Quality Control and Quality Assurance…….
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in Fist year sem I......
This Presentation Contain following...
#Definition
#Purchase Specification
#GMP & WHO guidelines for handling of raw materials
#Control on Raw Materials
#Sampling of Raw Materials
#Raw Materials Testing
Thanks for Help and Guidance of Dr. F. A. Tamboli Sir and Dr.Mrs. N.M.Bhatia Madam
role of quality system and audit in pharmaceutical manufacturing environment....MridulBindra2
M. pharma quality assurance
role of quality system and audit in pharmaceutical manufacturing environment.
topics covered are as follows
cGMP regulation
quality assurance functions
quality system approach
management responsibility
resources
The personnel is the most important asset of a company, and the easiest to neglect. The establishment and maintenance of a satisfactory system of quality assurance and GMP relies upon people who develop the system, the people who use the system and the people who examine the system to see if it has worked.
The technical people must have a knowledge and understanding of GMP to enable them to carry out their duties in accordance with GMP. These people must have the level of training and experience that will enable them to do their professional works respectively.
Tektronix keithley Product and Application update Q2 2016Jeff Sable
Tektronix delivers innovative, precise and easy-to-operate test, measurement and monitoring solutions that solve problems, unlock insights and drive discovery.
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A true innovation in Handheld XRF is detailed by this presentation and additional information can be requested through Eastern Applied Research - a regional distributor of Oxford Instruments.
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Improving RoHS Testing with X-ray Fluorescence by Hitachi
1. Improvements in RoHS Screening
by Hitachi High-Tech Science Corporation
(Eastern Applied Research, Inc. is responsible for the contents of this presentation.
Certain material is used with the permission of Hitachi High-Tech Science Corporation.)
Authorized Distributor;
United States and Mexico
Pb Hg CrBrCd
2. Hitachi EA Series
EA1200VX
Multi-functional; RoHS with Material ID Capability
Exclusively features Vortex® detector technology
EA6000VX
Premier system for RoHS, Coating Thickness, Element ID
High precision mapping, Micro spot analysis
EA1000A-III / EA1000VX
Entry level to high precision RoHS screening
Time saving new functions for high throughput
featured in this overview:
3. Focus: 1000A-III
Hitachi analyzers build on a history of success and reliability;
evolving from the industry leading Seiko analyzer
Seiko Model Hitachi Model Primary Use
SEA 1000A, 1000A-II 1000A-III RoHS dedicated
SEA 1200VX 1200VX RoHS and Material ID
SEA 5000 Series 6000VX RoHS, Coatings, Element ID
SFT 9500 FT-150 Thin Film, Micro Spot
3200, 9200, etc FT-110A Coating Thickness
5. New Components
spectral comparison of
500 mg/kg Pb in brass
Vortex ®
PbLa
PbLb
SEA1000AⅡ intensity
Intensity
15X
X-rayIntensity/cps
EA1000VX intensity
Improvements to detector technology results in higher
sensitivity in both the EA1000A-III and EA1000VX.
This means improved count rate, resolution, and speed.
(note: EA1000A-III intensity improved by 2x)
6. Faster Results
Cd, Pb, Hg, Br, Cr
in plastic
Cd, Pb, Hg, Cr in
high Br, Sb plastic
Cd, Pb, Hg, Br,
Cr in brass
SEA1000All 100 < 360 + 2000
EA1000Alll < 70 < 210 < 800
EA1000VX 30 < 120 < 200
Typical measurement times (average values) unit: seconds
Time to fall below Cd 20 mg/kg; Pb, Hg, Br, Cr 100 mg/kg at 3σ standard error
Improvements in analyzer components and configuration
allow the new Hitachi EA Series to rapidly increase
the number of samples that can be processed
7. Reduced Standby
Products Standby time/seconds
SEA 1000A-ll 75
EA1000VX 20
Improved efficiency by reducing system standby time when
starting a measurement and processing software
Compares total standby time for three measurement conditions
What is meant by standby time?
It is the time between each measurement to change the
measurement condition (analyzer configuration) for optimized results
So…faster standby time means faster throughput
8. Precision Control
Innovative precision control software stops the
measurement when target precision is achieved.
Benefit / Advantage
- Greater throughput with most efficient measurement time
-Do NOT need to set measurement time for each run
- Achieve good data without a specialized operator
Matrix A (Metal)Matrix A (resin)
Standarderror/mg·kg-1
Matrix C (Alloy)
Measurement times / sec
target precision
stopping point
9. Auto-Selection
Statistical error
3σ mg·kg-1
Hg La 185
Hg Lb 61
Software automatically finds overlapping element peaks and
selects the analysis line with the smallest statistical error.
8.0 10.0 12.0 14.0 16.0
ZnKa
ZnKb
HgLa
HgLb
Energy/keV
Intensity
CuKa
La of Hg is overlapped with Zn Kb.
So, its SE is greater than Lb of Hg.
Software chose Lb for analysis
NOTE: Software records why this line
was chosen, you can see that record.
10. Material ID
XRF results are affected by sample matrix and
must be analyzed with the appropriate calibration/recipe.
Fe alloy Resin Cu alloy
Previous models required an operator to manually select
recipes for each measurement. This can result in mistakes
as an operator’s judgment of a material could vary.
11. Material ID Benefit
Pre-measurement
Select recipe
Show result
Measurement
Save data
Sample set
This is your only task nowThese were your tasks
Material ID eliminates operation steps and
potential operator error because the
software automatically selects the proper calibration.
12. Database Sharing
Each software/PC has a database that can be shared
internally, across a network, and can perform
data search, view, analysis, reporting and printing.
13. Database Function
TRENDS COMPARE SEARCH
Quickly review trends
of the same sample
Easily compare data
and determine the
reason for an error.
Left end image
above was in the
wrong position
Simply search data
through any of
several search
methods
contact Eastern Applied for complete demonstration of software/database
14. Specifications
Description: EA1000A-III
Element Range: Atomic Numbers 13 (Al) to 92 (U)
Sample State: Solid / Powder / Liquid
X-ray Source:
Air Cooled X-ray Tube, Rh target
Variable voltage (15, 40, 50kV) and current (1mA)
X-ray Configuration: Bottom-Up Irradiation
Detector:
Si Semiconductor Detector (high speed, no LN2)
(high-speed Vortex®
detector available in 1000VX model)
Chamber: 14.5 x 12.5 x 4.7 (W-D-H, approximate in inches)
Collimators: 1mm, 3mm, 5mm (auto switch)
Sample Observation: Color CCD Camera
Filter: Five (5) mode, automatic switching (including off)
Interface: Desktop or Laptop computer and LCD monitor
Data Process: Microsoft Excel and Word Capable
Software:
Routine Measurement, Regulated Substance V2,
Qualitative and Quantitative Packages
15. Additional Analyzers
Additional analyzers in the Hitachi EA
Series offer the same features and benefits
of the EA1000A-III with added features.
Additional Features of the Hitachi EA6000VX
Mapping, High Speed and Precise See-through Analysis
Vortex® Detector comes standard High Precision Overlap Function
Continuous Multi-Point Measurements Light Element Capable
RoHS plus Thickness and Element ID Contaminant Analysis
16. More Information
EA1000A-III Info and Literature:
http://www.easternapplied.com/hitachi-1000AIII-xrf-analyzer
Complete EA Series from Hitachi:
http://www.easternapplied.com/hitachi-xrf-analyzers
Contact Eastern Applied Research Inc
for literature, demonstrations, discussions:
http://www.easternapplied.com/
716-201-1115 ~ sales@easternapplied.com