Medline Custom Pack Quality System

• It's our business to deliver quality– it's our business to produce quality– your quality output is our quality input
• We are a world leader in custom pack production and delivery for over 13 million surgeries in 2008
• We have perfected the custom pack manufacturing process and deliver unparalleled quality exceeding our customers expectations

Quality Highlights– Production– People– Process:

• All custom trays manufactured in cleanroom controlled environment for product and patient safety.
• Strict gowning and personnel control to reduce visual particulate and contamination of products.
• Supplier control and inspection process required for all raw material components.
• Every pack assigned picture driven visual assembly instructions for product placement to ensure each pack is made the same way– every time.
• No unauthorized substitutions– all changes required to be approved by customer
• On– line quality inspection for every customer to verify correct components/ design/visual and defect control.
• Every kit weighed to prevent missing assemblies.
• 99.99985% defect-free performance in over 1 million packs produced/month
• FDA/ISO registered production facilities
• Training for all manufacturing employees on component and kit design for maximum efficiency and basic surgical knowledge.
• All customer concerns logged, reviewed, and investigated. Response provided to customers on resolutions.
• Supplier corrective action procedure to monitor performance and improvement.
• Your partner in safety and environmental commitment through: SCIP, Gold Standard, Greensmart environmentally responsible components.

Sterile Procedure Tray Division

• 30+ Years In The Business
• House Over 35,000 Components For Pack Use
• Manufactures Over 1 Million Custom Packs a Month
• Over 2,700 Custom Pack Customers World Wide
• 1500 Employees
• 3 Plants
• Extensive Distribution Centers
• 4 Sterilization Locations
• Capacity for Growth

Custom Pack Quality Review

• Incoming Component Inspection
• Work in Process Picking and Set UP
• Work Order Verification
• Picture Driven Instructions
• Picking Accuracy/Counting
• On-Line Production
• FDA/ISO Standard Comliance
• ANSI/ASTM Sampling Plan based on SPC and Statistical Quantities Produced
• Post Assembly
• Insert, Carton Sizing and Packaging Review
• Post Sterilization
• Routine Sterilization Release Via Biological Indicators
• Residual Studies and Yearly Validation for Product Mix

Tips For The Care and Handling of Custom Packs

• Do not open shipping carton with a sharp object
• Personnel handling packs should not wear sharp jewelry or handle with long finger nails
• Use two hands when handling pack
• Do no pick up unsupported by the edges or drag on floor
• Store in a protective location away from dust, dirt and debris
• Storage shelves should be free of sharp edges
• Overstuffing shelves may crush or smash packs
• Inspect storage racks and shelving regularly for any rough or sharp edges