Note
For detailed information about the Procedure for
BIS ISI Certification, visit:
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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.
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.
Key Highlight
| 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 | View QCO |
| 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. |
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.
Process
Process for BIS ISI Mark Certification
A streamlined process designed to ensure compliance, quality, and efficiency at every step.
01
Documentation
Preparation and submission of required documents.
02
Application Submission
Filing the application with BIS along with applicable fees.
03
BIS Audit
Inspection and evaluation of manufacturing facility.
04
Sample Testing
Testing of product samples in BIS recognized laboratory.
05
Grant of License
Successful evaluation and grant of BIS ISI Mark license.
Learn the complete process
Watch our detailed video to understand each step involved in obtaining BIS ISI Mark Certification.
Timeline for BIS Certification
The estimated time frame for obtaining BIS certification under IS 16011:2012 is:
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.
Partner with Aleph INDIA to simplify your BIS certification journey and ensure full compliance with IS 16011:2012 for robust and high-performance packaging solutions.
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