05 May,2025 3 Views 0 Comments

BIS ISI Certification for Aluminium & Aluminium Alloy Foil for Pharmaceutical Packaging – IS 16011:2

BIS ISI Certification for Aluminium & Aluminium Alloy Foil for Pharmaceutical Packaging – IS 16011:2012

Ensure Timely BIS Compliance with A2Z BIS Solutions Pvt. Ltd.

In the pharmaceutical sector, packaging plays a crucial role in safeguarding the potency and shelf life of medicines. Aluminium and aluminium alloy foils are widely used in this field due to their excellent barrier properties against moisture, oxygen, and contaminants.

To uphold stringent quality standards, the Government of India has mandated BIS ISI certification for aluminium foils used in pharmaceutical packaging under IS 16011:2012. If you're a manufacturer or supplier in this domain, achieving BIS compliance is no longer optional—it's a legal requirement.

At A2Z BIS Solutions Pvt. Ltd., we offer complete consultancy support to help you secure your BIS license with accuracy and speed.

About IS 16011:2012 – The Standard in Focus

This Indian Standard specifies the technical requirements for bare, coated, and laminated aluminium foil for pharmaceutical packaging. It ensures the foil meets the necessary protective, mechanical, and sealing characteristics required in pharma applications.

Key Parameters under IS 16011:

• Thickness: 20 to 40 micrometers

• Barrier Properties: Resistance to moisture, air, and light

• Mechanical Strength: High bursting and peel strength

• Surface Quality: Defect-free (no wrinkles, slivers, pinholes, or stains)

• Coating & Sealing: Consistent lacquer application for heat-seal integrity

Compliance with this standard helps maintain product integrity, consumer safety, and regulatory approval.

BIS Compliance Deadlines

Under the Aluminium and Aluminium Alloy Products (Quality Control) Order, 2024, BIS certification is mandatory for aluminium foils used in pharmaceutical packaging.

Step-by-Step BIS Certification Process

1. Product Testing:
   Send samples to BIS-approved labs for testing as per IS 16011:2012.

2. Application Filing:
   Submit the application on the Manakonline portal along with required documents (test reports, factory details, QMS, etc.).

3. Factory Audit:
   BIS officers inspect your manufacturing facility and may collect samples for re-testing.

4. License Grant:
   Upon successful evaluation, BIS grants the ISI license with the IS 16011:2012 standard number.

5. Ongoing Compliance:
   Maintain quality standards for surveillance audits and random market sampling by BIS.

How A2Z BIS Solutions Pvt. Ltd. Supports You

With deep industry insight and real-time regulatory knowledge, we offer end-to-end support, ensuring a smooth and successful BIS certification journey.

Our Services Include:

• BIS Portal Registration & Documentation

• Testing Coordination with Recognized Labs

• Factory Audit Readiness & Compliance Review

• BIS Query Resolution & Objection Handling

• License Management & Renewals

Why Clients Trust A2Z BIS Solutions:

• Proven expertise in aluminium product certification

• Strong network with BIS officers and accredited labs

• Dedicated project managers for personalized support

• Focused on timely delivery and minimal disruptions

Conclusion

If you're in the business of pharmaceutical packaging using aluminium foils, now is the time to act. Early preparation and expert guidance can make the difference between smooth certification and costly delays.

Let A2Z BIS Solutions Pvt. Ltd. help you meet your BIS obligations without the hassle.

Contact Us Today:
A2Z BIS Solutions Pvt. Ltd.
Sector 117, Noida – 201304 (Delhi NCR)
Phone/WhatsApp: +91-9038159965
Website: https://a2zbissolutions.com

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