sterile medical device - innovative technology conferences jan2013... · sterile medical device ......
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Sterile Medical DeviceImpulse Sealer Validation:
Trials and Tribulations
Jan GatesPackWise Consulting
March 14, 2013
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Validation review Sealing review Sealing elements/information required for validation
work Commonly seen issues discussed Testing: equipment, method and people Validating Questions
General Outline
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FDA Process Validation General Guidance Document:– quality, safety, and effectiveness must be designed and
built into the product;– quality cannot be inspected or tested into the finished
product; and– each manufacturing process step must be controlled to
maximize the finished product probability for meeting all quality and design specifications
Validation Principals Review
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Pouch seals cannot be continuously tested; therefore, the seal made must be made on a validated process
The manufacturing process must be controlled
Pouch Seals and Validation Review
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Seal occurs when the hot materials melt and cool together
Three sealing parameters**– Time– Temperature– Pressure
**Vacuum/gas flushing may affect sealing, when used test to see with the product included
Sealing Review
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Safer than continuously on hot bar sealer Allows pouch seal to be handled quickly Low power consumption Typically lower initial equipment costs Quick and repeatable calibration Generally an easy validation Larger range of materials useable Maintenance required easier to see
Impulse Heat Sealers?
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We Have a Sealer
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We have Pouches
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Let’s Validate Sealing
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Regulatory Materials sealing Sterilization effects, if applicable Stability required Seal type Testing Production requirements Use environment Performance requirement
User Requirements, examples
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Design controls: 820.30 Production and process controls: 820.70 Inspection, measuring, and test equipment: 820.72 Device packaging: 820.130 Storage: 820.150 Distribution: 820.160 Installation: 820.170 Statistical techniques: 820.250
Regulations: FDA Quality System Reg
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Medical Device Directives– ISO 11607-1/-2: packaging requirements validations
– EN 868-2 to 10: making pouches
– EN ISO 11135-1: worst case loads
– Soon: ISO 16775, based on AAMI TIR22 Packaging and Packaging Waste Directives
– ISO 18601: packaging and the environment
– ISO 18062: packaging optimization
Regulations: European
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Tyvek to Tyvek Tyvek to Olefin coated Nylon or PET Tyvek to something else Olefin coated nylon, PET, foil, paper, or other What type of Olefin:
– LDPE– LLDPE– Additives: EVA, Surlyn, antistatic, blocking agent, or
something else
Other
Materials
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Sterilization affects– AAMI TIR 17 and suppliers are helpful
Aging – Brittle, bloom, static, ultra-violet light, etcetera
Storage temperatures– Before and after pouch use
Seal Type – Tack (peel) or weld seal– Multiple bands, ridges, cross hatch, other
Product exposure– Changes with time, light, temperature, other
Stability
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Basically two:– Weld– Tack/Peelable
Other options:– Patterns in the seal– Multiple lines– Heating band shape
Seal Type
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Visual test (ASTM F1886)
Seal test (ASTM F88)
Burst test (ASTM F2054, restrained, and ASTM F1140, unrestrained)
Dye penetration (ASTM F1929)
Pressure decay (ASTM F2095)
Other
Seal Testing
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Seal Testing Notes:
Seal Coupon
• Seal strength testing on a one inch wide coupon– Seals are generally wider than one inch
• Multiple seal coupons on one seal needed – Depends
• Entire seal length tested for a continuous seal Sealfailure at sealant layer or adhesive layer
– May be important • Seal strength may change with sterilization
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Seals made per day Cooling time required Preventative maintenance (PM) Testing after PM Training/trouble shooting Pouch insertion Handling after sealing Vacuum/flushing Product fit
Production Requirements
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Clean room/classification Power Air Gases/Vacuum Heat exchange system(s) Safety features Pouch guidance features
Use environment
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Storage Handling Distribution environment Customer use
Performance Requirements
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User Requirements Done–Let’s Validate Sealing
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Know your impulse sealer basics:
Before Equipment Installation
SpringBar
Heating wire/band
Cushion
Non-stickcovering
Other bar side
Thermocouple
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Bars parallel Bars flat Bars aligned Spring flexible Heater wire/band length Cushioning flexible Non-stick covering on both sides
Equipment Basics
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Consistent and even pressure
Pressure #1
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Consistent and even pressure
Pressure #2
Pressure #3
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Bars and Seal Cooling
Cushioning
Heater BandNon stick covering
Bar
Cushioning
Non-stick covering
Bar
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Placement, type, attachment, response time
Thermocouple
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Thermocouple Response Time
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Often called: silicon rubber Important to know:
– Durometer– Thickness– Shelf life/aging– Consistency
Cushioning
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Often called: Teflon or glass webbing Important to know:
– Weave– Coating– Thickness– Adhesive placement
Non-Stick Covering
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Do not depend on line workers to see all issues Consumable equipment parts:
– use validated parts or revalidate– set-up equipment checks with replacements– shelf life must be considered
Moving parts must be monitored Flat, parallel, and perpendicular surfaces must be
monitored Process monitoring needed for seal strength drifting
Notes on Preventative Maintenance
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Installation Qualification (EIQ)
Operational Qualification (EOQ)– Minimum/Maximum temperature– Pressure consistency– Timing range– Other options
Equipment Installed and Operating
– Powers up – Alarms work
– Jaws close – Safety features function
– Bars flat, parallel, aligned – Other
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Equipment Operational Qualification (EOQ)– Keep process development and packaging qualifications
activities separate from EOQ
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Packaging Equipment, EOQ
EOQ ParametersLow High
Material Sealing Parameters
LowLowMaterial 2Material 1 High High
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IQ/OQ Done– Let’s Validate Sealing
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Determine sealing parameters– Design of experiment (DOE) best – Testing from no seal to burnt seals– Find the maximum and minimum settings
Develop Sealing Parameters
Pressure
Temperature
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Under/Over Seal Limits
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Normally use: ASTM F88 - Standard Test Method for Seal Strength of Flexible Barrier Materials
Validate the test method at the laboratory– Cut sample coupons correctly– Mount coupons for testing correctly– Understand the test curve– Test peak or average– Calibration correct on test equipment
Use statistical samples sizes and analysis Burst strength based on acceptable
seal strength
Notes on Seal Testing
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Seal Parameters Set – Let’s Validate
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How many sealers validating?– One sealer, continue on– Validating more than one sealer
Decide whether validating each sealer or grouping If grouping sealers must determine whether the equipment
all seal the same Normally the same model sealers do not seal alike Often easier to validate equipment individually than group
but not always economical
Validate to the process using
Sealing Equipment
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Let’s Validate the Sealing
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Engineering tests conducted with product or simulated product first
Write protocol and document– Sealing parameters– PM, equipment change parts– Document calibration– Process speed– Materials used– Acceptance criteria– Statistical analysis
Validate the Sealing
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Magic sampling number does not exist Magic minimum seal strength does not exist Statistical analysis relies on normal data distribution
– Seal strength data is often not normal– Transforming seal strength data does not always work– Have a plan for non-normal data in the protocol
Statistical sampling dependent on a company’s acceptable risk level
Statistical Notes
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Packaging System OQ/PQ
PQ
OQ
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Required by the FDA and ISO Standards Process monitoring ≠ minimum seal strength Tests used:
– Visual– Seal strength or burst strength– Pressure decay– Others
Periodic review
Process Monitoring
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The manufacturing process must be controlled– Know your equipment– Set up appropriate PM– Validate testing methods– Determine the sealing limits and set production process
well within– Monitor the process
Test an appropriate sample size for OQ and PQ
Summary
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PackWorld USA (Sealers) Accu-Seal Corporation (Sealers) Sencorp White (Sealers) VanderStahl (Sealers) Vertrod (Sealers) Beacon (Pouches) Oliver Tolas (Pouches) Mangar Medical Packaging (Pouches)
Thank You for Pictures and Comments
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Questions?
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Contact
Jan GatesPhone/Cell: 650.743.5780E-mail: [email protected]: http//www.packwiseconsulting.com/Based in Temecula, CA
48 2013