BIS CERTIFICATION FOR ALUMINIUM AND ALUMINIUM ALLOY FOIL FOR PHARMACEUTICAL PACKAGING IS 16011:2012

BIS certification is a requisite for pharmaceutical packaging aluminum and aluminum alloy foils. According to IS 16011:2012, the adaptability of wrought aluminum and aluminum alloy bars, rods, tubes, sections, plates, and sheets, owing to their simplicity in fabrication and recyclability, enhances their applicability across diverse engineering sectors.

In electrical engineering, aluminum and its alloys are pivotal in numerous applications like electrical enclosures, busbars, generators, transformers, motors, and power transmission and distribution systems. Their crucial characteristics such as electrical conductivity, lightweight structure, and resistance to corrosion significantly influence the design and development of power systems, while also fostering sustainability through minimized energy usage and environmental footprint.

The IS 16011:2012 standards set forth rigorous criteria for wrought aluminum and aluminum alloy bars, rods, tubes, sections, plates, and sheets utilized in electrical contexts, encompassing mechanical attributes, electrical conductivity, and chemical makeup. This standard is applicable to extruded angles, channels, diverse profiles, tubes, and hollow sections with a thickness exceeding 3 mm, along with extruded bars and rods with a diameter greater than 6 mm.

Key Highlights

Product Name	Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging
Applicable Indian Standard	IS 16011: 2012
Applicable Certification Scheme	Product Certification Scheme (ISI Mark Scheme) Scheme 1 - Schedule 2
Compliance Requirement	Mandatory
QCO Link	Quality Control Order
Scope as per Standard	This standard encompasses the specifications for aluminum and aluminum alloy foils, whether bare, coated, or laminated, intended for pharmaceutical packaging purposes. It applies to foil thicknesses ranging from 0.020 mm (20 µm) to 0.040 mm (40 µm).

TESTS

The following are the major tests for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging:

Pin Hole Count
Freedom from Defects
Average Thickness of bare foil
Coating/Lamination
Width
Bursting Strength
Peel Strength
Sealing Strength
Material
Lubricants

An important factor to highlight is the compulsory requirement of the ISI Mark, which serves as a verification of adherence to the precise specifications of IS 16011:2012. Lack of this certification prohibits the marketing, import, or export of these products in the Indian consumer market.

BIS Certification Process

Acquiring a BIS license entails a detailed evaluation of manufacturing infrastructure, quality control capabilities, testing facilities, and production processes. This thorough assessment guarantees that the products not only meet regulatory standards but also ensure safety and reliability for consumers.

NOTE:

For comprehensive guidance on the BIS ISI Certification process, please explore:

Timeline

The estimated duration to acquire BIS Certification for Aluminum and Aluminum Alloy Foil intended for Pharmaceutical Packaging, in order to utilize the ISI mark as per IS 16011:2012, is outlined below:

For Indian Manufacturers (Standard Timeframe – 30 days)
For Foreign Manufacturers (Standard Timeframe – 180 days)

WHY USE ABSOLUTE VERITAS?

Absolute Veritas is a prominent organisation from the private sector of India primarily dealing with the Inspection, Testing, Audits, Certification of products& consulting services to various industries in India and worldwide, ensuring compliance with regulatory standards and industry requirements. Offering a comprehensive range of services including product certification, testing, training, auditing, and compliance services, Absolute Veritas helps manufacturers and importers achieve higher production efficiency and quality standards.

Absolute Veritas (AV) will handle end to end pre-registration request, sample preparation, documentation, testing and application process for FMCS Certification

For any questions regarding the most recent update on FMCS registration licenses, please reach out to us via email at cs@absoluteveritas.com