PDA TR05 Sterile Pharmaceutical Packaging Compatability and Stability
Role of Packaging in Stability Studiesipapharma.org/events/Stability/Associate capsules 2.pdf ·...
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Your global partners in solid dosage systems Role of Packaging in Stability Studies • Blister Packing Technology - R . Khimsaria • Blister Packing Materials - H . Mhatre • Selection Criteria - J . Bhat
Transcript of Role of Packaging in Stability Studiesipapharma.org/events/Stability/Associate capsules 2.pdf ·...
Your global partners in solid dosage systems
Role of Packaging in Stability Studies
• Blister Packing Technology - R . Khimsaria
• Blister Packing Materials - H . Mhatre
• Selection Criteria - J . Bhat
Your global partners in solid dosage systems
Your global partners in solid dosage systems
• Derive suitable packaging on dosage form • Protection from Moisture, Gas, Light & Temperature• Microbiological Integrity • pH Stability• Anti – Counterfeit Capability• Compliance – Regulatory & Patient
Importance of Pharma Packaging
Your global partners in solid dosage systems
• Blister packs• Strip Packs• Bottles for bulk packs• Sachets or Pouches• Tubes for oral dosage • Injectables• Suppositories
Packaging formats in Pharma Industry
Your global partners in solid dosage systems
• Single source for all your blister needs
• Solutions for both Blister machines and foils
• Closely associated with ALCAN Packaging & HONEYWELL for Barrier foils
• Application development at R&D and Clinical stage
Our Competence – BLISTER TECHNOLOGY
Your global partners in solid dosage systems
Types of Blister Packing process
- Forming principle is either Vacuum or Compressed Air Thermoforming & Plug assist for Cold forming
Your global partners in solid dosage systems
Types of Blister Packing process
1. Vacuum based Rotary Thermoforming:
Your global partners in solid dosage systems
2. Compressed air & Plug assist Platen forming:
Types of Blister Packing process
Your global partners in solid dosage systems
• Low barrier film – PVC
• Medium barrier film – PVdC
• High barrier film – ACLAR & ALU/ALU
Barrier Packaging foils
Your global partners in solid dosage systems
• Push through blisters with ALU lid stock – Most common
Types of Blisters: Push Through Blister
Your global partners in solid dosage systems
• Peelable paper with Paper+ALU Lid stock – Child resistant blister
Types of Blisters: Peel Push Blister
Your global partners in solid dosage systems
• Tropical Blister – combination of PVC/ALU + ALU Tray – Product Differentiator
Types of Blisters:
Your global partners in solid dosage systems
Blister Sealing Patterns:
Dot Type Sealing:
DiamondType Sealing:
Your global partners in solid dosage systems
Designing a Blister:
• Analysis of current pack• Required barrier properties • Preparing a Blister format drawing
Your global partners in solid dosage systems
PVC blister pattern:
Your global partners in solid dosage systems
PVC blister pattern:
Your global partners in solid dosage systems
ALU blister pattern:
Your global partners in solid dosage systems
ALU blister pattern:
Your global partners in solid dosage systems
TROPICAL blister pattern:
Your global partners in solid dosage systems
Some special formats:
Your global partners in solid dosage systems
R&D Blister machines available:
• Platen type machines• Suitable to pack pre-formed blisters
Your global partners in solid dosage systems
MINIBLIS –‘Small Wonder in Blister Packing’:
• Suitable for R&D and Clinical trials• Runs with all forming foils – PVC, PVdC, ACLAR,
ALU/ALU & all lidding foils• Auto feeding facility to replicate results at Scale up
Your global partners in solid dosage systems
• Universal tooling:Lack of gauge controlUneven cooling
• Matched tooling:Ideal for best results
Tooling design:
Your global partners in solid dosage systems
Temperature Parameters (In °C):
Your global partners in solid dosage systems
Optimizing Material Heating:
• Contact Heating is recommended
• Platen surface: Minimize friction
• Sealing temperature & pressure
• Cool as well as possible
Your global partners in solid dosage systems
• IN COLD FORMING:- Mechanical forming by PLUGS- Plug material – TEFLON
• Can cause formation of Pin-Holes or Material Tear
• Installing PIN HOLE DETECTORS for forming and lidding foils
More Aspects to be considered:
