Lean Strategies for Laboratory Testing

Jenny Watson Global Pharmaceutical Applications

Manager GE Analytical Instruments

Agenda

• Operational Excellence & Lean • Case Study

The Balancing Act Time

Scope Cost

Quality

Operational Excellence & Lean Lean Methodology • Focus on organizing

human activities • Reduce the 7 wastes

Operational Excellence • Organizational leadership

strategy • Applies a variety of

principles, systems, and tools to improve key performance metrics

• Includes application of new technology

Transport Inventory Motion Waiting

Overproduction Over processing Defects

Evaluation • SOPs • Business Practices • Technology

– Example: New Instrumentation, New Manufacturing Technology

• Data Handling – Example: Laboratory Data Management Systems,

Electronic Batch Records

What areas does this apply?

• Manufacturing • Process Development • Quality Systems • Quality Control

Looks at Procedures and New Technologies

Quality Control

• Environmental Monitoring • Ongoing Operational Testing • Final Product Testing • Stability Testing • Maybe Process Development Testing

Case Study: Evaluation of Lab Testing for Water Samples

Customer Current State

– Sample collection, testing, data entry, and review of 50-200 samples/week

– Stage 1 or 2 Conductivity performed in lab – Manual analysis – Data transcription

P.O.U. Sampling

Transfer to Lab

Set up Manual Analysis

Analyze for Stage 1

Manually Record Results

Analyze for Stage 2 (if

fails)

Transpose Results to

LIMS

Conductivity

Conductivity Background

• USP requires conductivity monitoring for bulk purified water and water for injection

• USP <645> Water Conductivity provides the following guidance:

Stage 1

• Measured Online or Offline in suitable container • Measure temp & raw conductivity • Compare to Pass/ Fail criteria

Stage 2

• Offline test • 100 mL sample • Temperature control (25°C) • Vigorous agitation • Conductivity measurement must stabilize (Δ ≤ 0.1 µS/cm over 5 min) • Pass if sample < 2.1 µS/cm

Stage 3

• Uses sample from Stage 2 within 5 minutes • Addition of KCl salt to sample • Measure pH • Determine corresponding conductivity • Value must be less than conductivity measured at Stage 2

USP <645> Conductivity < 15 min

~ 4 hours

~ 6 hours

Instruments and Consumables Current State Future State

The Challenge Conductivity and TOC measurements typically require different

sample containers

Measured in Plastic

• Glass has ionic interferences

Measured in Glass

• Plastic leaches TOC

DUCT Vials

Conductivity Total Organic Carbon

Solution

Customer Success

A large, global pharmaceutical company wanted to lean out processes, gain efficiency, and reduce costs related

to TOC and conductivity testing

• Purchased Sievers M9 Laboratory Analyzer for simultaneous TOC and

Conductivity measurements with DUCT Vials • Integrated instrument with laboratory data management system for

paperless workflow • Determined payback period and savings based on labor and costs

Implementation

Method Transfer Activities Conductivity Manual to Automated

• Stage 1 Conductivity on the M9 viewed as automated

• Accuracy, Precision and Linearity performed to establish suitability

TOC Upgraded to Current Model

• Instrument Comparability

• Container Comparison

• Side by side testing

TOC Method Transfer Results

80

85

90

95

100

105

110

115

120

Run 1 Run 2 Run 3

% R

espo

nse

Effic

ienc

y

DUCT VialSystemSuitability Kit

Borosilicate VialSystemSuitability Kit

900 BorosilicateVial SystemSuitability Kit

Acceptance Criteria = 85-115%

Integration with Lab Data System

Original Process – Conductivity was recorded on controlled worksheets and

then manually entered into lab data system – Results were then reviewed/approved by quality

New Process

– Results automatically transferred to lab data system • No review/approval required • Generated data module to accept conductivity

measurements

Streamlined Process

P.O.U.

Sampling Transfer to

Lab

Set up Manual Analysis

Analyze for Stage 1

Manually Record Results

Analyze for Stage 2 (if

fails)

Transpose Results to

LIMS

Current State Compendia Process Flow:

P.O.U. Sampling

Transfer to Lab

Set up Analysis

Analyze TOC & Cond.

Go To Stage 2 if Fail

Results direct to

LIMS

Future State TOC and Conductivity Process Flow:

P.O.U. Sampling

Transfer to Lab

Set up Analysis

Analyze TOC

Results direct to

LIMS

Conductivity

TOC

Payback Period: Cost per Sample Cost Type Current Future

Cons

umab

les Conductivity Sample Containers & Verification Standards $ 2.58 $ 15.70

TOC Sample Containers $ 4.83 N/A TOC Verification Standards No change

Total Consumable Cost per Sample $ 7.41 $ 15.70

Labo

r Analysis Time (minutes) 7 2

Labor Rate per sample $1.17 $1.17

Total Labor Cost per Sample $ 8.17 $ 2.33

PM

Maintenance per sample (PM cost divided by # samples per year) $ 0.44 $0.88

Overall Total Cost per Sample $ 16.01 $18.91

Current Future

• 40 mL TOC vial • 125 mL Conductivity bottle • 125 mL Conductivity back-up

• 30 mL DUCT vial • 125 mL Conductivity back-up

Payback Period Cost Factors Current Process Future Process

Instrument & Installation Costs N/A $ (99,710)1 Labor Costs $ (115, 500) $ (16,500) Consumable Costs $ (122, 220) $ (129, 500) Maintenance Costs $ (14, 484) $ (14, 484) Projected Labor Savings N/A $ 62,400 Total Cost $ (252,204) $ (197, 794) Overall Cost Savings N/A $ 54,410 Payback Period (months) N/A 8

Based on labor rate of $60/hour Labor rate = $40/hour; payback is 12 months

Summary

When evaluating opportunities for more efficient operations it is important to look at the whole process. How could a new technology change my overall process?

Jenny Watson Global Pharmaceutical Applications Manager

W +1 720 622 0241 C +1 303 349 0103

Email: jenny.watson@ge.com 6060 Spine Rd

Boulder, CO 80301-3687 USA

www.geinstruments.com