ddl overview 2009
TRANSCRIPT
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
and
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year GrowthDDL - West
DDL – Eden Prairie
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
Professional Associations• Chairman for the ASTM Committee D-10 on
Packaging• Involved with ASTM since 1981 • Member of the AAMI committee to draft a
Technical Information Report (TIR)• Institute of Environmental Sciences (IES) • Society of Automotive Engineers (SAE)• ISTA Certified Lab• DOT Third Party Testing Lab• IoPP Members (8 Staff are members)• Member of LifeScience Alley (formerly Medical
Alley)
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
Testing Capabilities• Medical Device Package Testing
• Pharmaceutical Package Testing
• Environmental Package Testing
• Hazmat Package Certification
• Mechanical Testing
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
Medical Device Package Strength and Integrity Testing
Seal Peel Testing –ASTM F88
Bubble Leak Testing –ASTM F2096Dye Penetration Leak Testing ASTM F1980
Burst Testing - ASTM F1140
Package Strength Tests
Package Integrity Tests
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
Dynamic Testing Equipment Resources
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
Thermal Package Performance TestingStability TestingOver a 72 – 120 hour timeframe, DDL conducts a stability test and develops a specification designed to inform pharmaceutical package testing clients of conditions that will push a thermal container out of the 2-8 centigrade (an indication that contents may lose active ingredients or even spoil) desired shipping
and storage temperature.
Thermal Performance over time for Profile #1
Thermal Performance over time for Profile #2
Thermocouple set-up in package
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
Environmental Testing Equipment Resources
45 Chambers in MN
8 Chambers in CA
1 cu.ft. to 900 cu.ft.
-70C to 200C
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
Material Testing Equipment Resources
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
Project Process Flow
Marketing
Sales AdminLab
ProjectManagement
LabTechnician
ProjectManagement
QualityAdmin
Inputs: CustomerSatisfaction Survey,Report Card Survey,
QIC meeting info,Strategic Planning
Meeting info
Outputs: MarketStrategy, Direct
Mailings, ProspectLeads
Inputs: MarketStrategy,
Prospect Leads,Web 'ContactUs' form, Price
list
Outputs:Quotes,
Protocols,Customer PO,
Contract Review
Inputs: Jobfile,
CustomerPO
Outputs: Jobslogged in
Peachtree andDDL tracking,Job number
Inputs: Job file,calibration status,equipment status,
job load status,SOPs and work
instructions
Outputs:Project
assignment,Lab tech and
testingschedules
Inputs: Projectassignment, Lab techand testing schedule,equipment status, testsamples, SOPs and
work instructions
Outputs: Intro tocustomer,Schedule
finalized, testingrequirements to
Lab tech,worksheets
Inputs: testsamples, project
info, testrequirements,
workinstructions
Outputs: Rawdata, pictures,
test statusinformation
Inputs: Raw data,pictures, test
status, worksheets
Outputs: Data analyzedand recorded, projectupdated, Report draft,
Invoice draft,communication to
customer, disposition ofsamples, report
customer survey card
Inputs: Report draft,signed report final,
project file, customercompleted report card
Outputs: ReviewedReport draft, signed finalreport draft, project file,
report card trending
Inputs: Draft invoice,final invoice, project file
Outputs: Draft invoice,final invoice
Strategic Planning andQIC Meetings
Inputs: Customer SatisfactionSurveys, Report Card Surveys,
Management Process Reviews,
Outputs: Corporate Vision, Mission,Goals, Objectives and Values,
Departmental Plans
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
CA/PA
Amendments
DocumentControl
Records
Customers
Satisfaction
Management Responsibility
Service Deviaions
Customer Complaints
EmployeeRecommendations
Internal Audits
Customer Audits
Calibration &Equipment
QualificationsSales Contract
Review
Project ContractReview
Preventive Mainetance
Training
Purchasing
Test Method, Equipment,Procedural (Policy), Supplier,Facilites/Workenvironment
DirectInDirect
Surveys, Report CardsOne-on-one, phone, email,
letter
Quality Management Process
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
Common Packaging Mistakes
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
ISO 11607 -Key Points• Proof of sterile barrier integrity (by physical means) is
sufficient to demonstrate sterility of the product.
• Medical devices with the same package system may be grouped for purposes of package system validation.
• The worst case package configuration must be determined, documented, and used for testing for compliance…this will require performing ‘process validation’.
• Results of the design development process shall be documented, verified and approved prior to product release.
• Physical testing (e.g. bubble leak, dye penetration, etc.) along with microbial barrier testing of materials can be used to demonstrate sterile barrier integrity.
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth
ISO 11607 Key Points• Use Standardized Test Methods.
• Testing is performed on packages produced at the lower limits of the process parameters established during compliance with Part 2 of this standard.
• The package system must provide adequate protection to the product through the rigors of handling, distribution and storage. (Laboratory distribution simulation or actual ship testing).
• Accelerated aging is sufficient evidence for expiry dates until real time aging is completed. Accelerated and real time studies should begin simultaneously.
• Stability testing and performance testing are separate entities
About Us – DDL’s 17 Year GrowthAbout Us – DDL’s 17 Year Growth