Data Integrity

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21 CFR Part 11, Data Integrity, electronic records, electronic signatures

How Sepha Products Simplify Pharmaceutical Regulatory Compliance

How Sepha Products Ensure Data Integrity in Pharma

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Founded in 1980

SEPHA has established a global reputation for innovation and development of specialised, high quality equipment for use in the manufacture of pharmaceutical blister packs, medical device and healthcare products. Our products enable customers to create high quality blister packs, to accurately detect leaks and weak seals in packaging, and to recover high value products from blister packs.

Products

Leak Testing
Deblistering
Packaging

Connectivity

MESConnect

Container Types

Blister Packs
Bottles
IV Bags
Vials
Ampoules
Pre-filled Syringes
Flexible Packaging
Medical Device Packaging

Standards & Regulations

ASTM F2338-24
ASTM F3169-16
USP 1207
21 CFR Part 11

Test Methods

CCIT
Vacuum Decay
Pressure Decay
Force Decay
Vacuum Deflection
3D Volumetric Measurement

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