Sterile Barrier Packaging for Medical Devices in India — Standards, Validation & Best Practices

Bhavya Shah
Nov 22
3 min read

A Practical Guide by Steris Surgical Solutions – India’s Trusted ETO Sterilisation & Packaging Partner

India's medical device manufacturing industry is expanding rapidly, but packaging failures and non-validated sterile barrier systems (SBS) are still a major cause of regulatory non-compliance, product recalls, and audit findings. Even if sterilisation is successful, any packaging breach can compromise sterility.

This blog by Steris Surgical Solutions, a leading provider of ETO sterilisation and sterile packaging support services in India, explains how to design, validate, and maintain SBS to meet CDSCO, ISO 11607, and international regulatory standards.

🔍 What is a Sterile Barrier System (SBS)?

A Sterile Barrier System is the packaging configuration that allows a medical device to be sterilised, remain sterile throughout transportation and storage, and be opened aseptically in the clinical environment.

Core SBS Functions

SBS Function	Requirement
Microbial barrier	Prevents contamination
Sterilisation compatibility	Allows EO, Gamma, Steam, or VHP penetration
Mechanical protection	Prevents damage during handling
Aseptic presentation	Allows sterile removal during surgery/use

👉 At Steris Surgical Solutions, we often receive devices from OEMs for ETO sterilisation that fail packaging validation. We now support our clients with SBS review before sterilisation to avoid costly rework and risk.

📦 Sterile Barrier Packaging Materials Compatibility (India Focus)

Sterilisation Method	Suitable SBS Materials	Risky Materials
Ethylene Oxide (ETO) (Steris Surgical Solutions' core service)	Tyvek, medical-grade paper, PET/PE films	Non-porous rigid trays
Gamma / E-Beam	PET, HDPE, PP	Tyvek (may discolor)
Steam	Paper/non-woven	Plastic, heat-sensitive laminates
VHP	Tyvek, high-permeability films	Standard foils

⚠ 60% of Indian device manufacturers we interact with select low-cost packaging without validating it for the intended sterilisation method — a common reason for CDSCO non-compliance.

📜 Indian Regulatory Requirements

To sell or export medical devices in India, packaging must comply with:

Regulation / Standard	Applicability
CDSCO Medical Device Rules (MDR) 2017	Mandatory
ISO 11607-1:2019	Packaging system requirements
ISO 11607-2:2019	Sealing & process validation
ISO 14971	Risk management
ISO 13485	QMS compliance

💡 Steris Surgical Solutions helps manufacturers align their SBS with ISO 11607 and supports technical documentation for audits and process validations.

🏭 SBS Design Considerations

Factor	What to Consider
Device geometry	Sharp edges? Flexible components?
Sterilisation type	EO vs Gamma vs Steam
Storage & transit	Indian tropical climate, long-distance shipping
Number of units per pack	Overloading causes seal stress
Aseptic presentation	Packaging opening method

Person in lab coat and hairnet inspects a blue and clear plastic blister packaging in a sterile lab setting. Focused and attentive mood. — Blister Sterile Barrier for Medical Devices

🧪 ISO 11607 Packaging Validation Process (India-Specific Guide)

Validation Area	Required Tests
Seal integrity	ASTM F88 (peel), F1929 (dye), F2096 (bubble)
Aging studies	Accelerated & real-time
Transportation simulation	ASTM D4169 / ISTA 3A
Material qualification	Compatibility & sterility retention
Process validation (IQ/OQ/PQ)	Heat sealing, EO-compatible configuration

💬 Steris Surgical Solutions now offers support in coordinating seal integrity testing and reviewing packaging validation reports as part of sterilisation consultancy.

🚨 Common Packaging Failures Seen in India

Issue	Impact
No packaging validation	Regulatory rejection
Incompatible materials used for ETO	Sterility failure
Weak sealing / over-multiple packing	Damage during transport
No transportation simulation	Micro-leak pathways
Relies only on sterilisation certificate	false security

🔎 Almost 30% of outsourced sterilisation cases Steris Surgical Solutions handles require repackaging before ETO due to inadequate SBS design.

🤝 Why Choose Steris Surgical Solutions?

“From packaging review to ETO sterilisation and validation documentation — we support your device until it’s audit-ready.”

Services We Offer	Value to Manufacturers
📍 ETO Sterilisation (Validated)	For Class A & B devices
📦 Packaging consultancy & selection	Avoids failure during sterilisation
📊 SBS documentation support	ISO 11607 compliance
🧪 Cycle validation reports	Regulatory submissions
🔍 Aeration, degassing, bioburden support	Full sterilisation lifecycle
🚚 Safe logistics for sterilised devices	Especially for temperature/humidity control