BIS certification for Aluminium and aluminium alloy foil for pharmaceutical packaging IS 16011:2012

BIS certification is mandatory for aluminium and aluminium alloy foils for pharmaceutical packaging. As Per IS 16011:2012 The versatility of wrought aluminium and aluminium alloy bars, rods, tubes, sections, plates and sheets, due to their ease of fabrication and recycling, increases their utility in various engineering fields.

In the field of electrical engineering, aluminium and its alloys play an important role in various applications such as electrical enclosures, busbars, generators, transformers, motors and power transmission and distribution systems. Their indispensable properties including electrical conductivity, lightweight nature and corrosion resistance make important contributions to the design and construction of power systems, as well as promote sustainability by reducing energy consumption and environmental impact.

The stringent requirements outlined in IS 16011:2012 for wrought aluminium and aluminium alloy bars, rods, tubes, sections, plates and sheets used in electrical applications include mechanical properties, electrical resistivity/conductivity and chemical composition. This standard applies to extruded angles, channels, various sections, profiles, tubes and hollow sections with a thickness of 3 mm or more, as well as extruded bars and rods with a diameter of more than 6 mm.

Key highlights

Product Name	Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging — Specification
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 covers the requirements of aluminium and aluminium alloy-bare / coated / laminated foil for pharmaceutical packaging applications. It is applicable for 0.020 mm (20 µm) to 0.040 mm (40 µm) foil thicknesses.

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

A notable aspect is the mandatory role of the ISI Mark, which serves as identification of compliance with the exact standards of IS 16011:2012. Without this certification, marketing, import or export of these products in the Indian consumer market is prohibited.

BIS Certification Process

Obtaining a BIS license involves a thorough assessment of manufacturing infrastructure, quality control capabilities, testing facilities, and production processes. This comprehensive evaluation ensures that the products not only comply with regulations but are also safe and reliable for consumers.

ALSO READ: BIS QCO for the Aluminium and Aluminium Alloy Products (Aluminium and aluminium alloy foil for pharmaceutical packaging)

NOTE:

For Detailed Information about the Procedure for BIS ISI Certification, Visit :

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Procedure for Domestic Manufacturer
Procedure for Foreign Manufacturer

Timeline for BIS Certification

The approximate timeline to obtain BIS Certification for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging. to use ISI mark as Per IS 16011:2012 is given below:

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

Conclusion:

The implementation of the Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging — Specification (Quality Control) Order, 2023, is ushering in a transformative era for the market of Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging — Specification in India. Manufacturers, by embracing these guidelines and securing BIS certification, are not merely complying with regulations; they are setting new benchmarks for excellence in the industry. Opting for BIS-certified Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging — Specification signifies more than a product purchase; it represents a commitment to dependability, superior quality, and safety.

BIS certification for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging — Specification goes beyond meeting regulatory checkboxes, assuring the highest performance standards in these products. In an era where quality takes precedence, choosing BIS-certified Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging — Specification guarantees a product that is not only dependable but also of the finest quality.

In this landscape of evolving standards, Aleph INDIA stands as a leading BIS consultant in India, dedicated to assisting manufacturers and importers in obtaining BIS licenses for their products. With a commitment to excellence, Aleph INDIA ensures that your products not only meet but exceed the required quality benchmarks. Aleph INDIA has been serving the industry as a single-window operator for all product regulatory compliance. We can assist importers or manufacturers in meeting all criteria for importing or selling a product in the Indian market.