UPCOMING QCO ON TEXTILE GOODS BY MINISTRY OF TEXTILE
BIS ISI Certification for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging IS 16011:2012
Aluminium and aluminium alloy foils are widely used in pharmaceutical packaging applications where product safety, hygiene, and protection are critical. These foils are used for packaging medicines such as tablets, capsules, and other healthcare products, ensuring protection from moisture, light, contamination, and environmental factors.
Indian Standard IS 16011:2012 specifies the requirements for aluminium and aluminium alloy foil used in pharmaceutical packaging. The standard covers bare, coated, and laminated foils and defines requirements such as thickness, mechanical strength, sealing performance, and material properties to ensure product integrity.
BIS ISI Mark Certification is mandatory for aluminium foil used in pharmaceutical packaging. Manufacturers must obtain BIS approval to ensure compliance with Indian safety and quality standards before manufacturing, importing, or selling these products in India.
Key Technical Requirements for Aluminium Foil for Pharmaceutical Packaging (IS 16011:2012)
- (i) Thickness range typically between 20 µm to 40 µm
- (ii) Freedom from defects such as pin holes and surface imperfections
- (iii) Uniform thickness and dimensional accuracy
- (iv) Adequate bursting strength and mechanical performance
- (v) Proper coating or lamination quality where applicable
- (vi) Sealing strength and peel strength requirements
- (vii) Use of suitable base material and lubricants
- (viii) Compliance with hygiene and pharmaceutical packaging standards
Overview of ISI Mark Certification for Aluminium Foil for Pharma Packaging
Aluminium foil used in pharmaceutical packaging plays a critical role in protecting medicines from contamination, moisture, and environmental exposure. These foils must meet strict quality and performance standards to ensure safety and shelf life of pharmaceutical products.
IS 16011:2012 defines key performance parameters such as thickness, strength, sealing properties, and material quality. Compliance ensures that the foil is suitable for pharmaceutical packaging applications and maintains product integrity throughout storage and distribution.
BIS ISI certification verifies that manufacturers maintain proper manufacturing processes, quality control systems, and testing facilities before granting permission to use the ISI mark on aluminium foil products.
Process Required for BIS ISI Mark Certification for Aluminium Foil (IS 16011:2012)
To obtain BIS ISI certification for aluminium and aluminium alloy foil used in pharmaceutical packaging, manufacturers must follow the BIS Product Certification Scheme (Scheme I). This ensures that products meet safety, quality, and performance requirements before entering the market.
Estimated Timeline: BIS ISI certification for aluminium foil generally takes around 30–45 days for Indian manufacturers
Step-by-Step Certification Process
- Application Submission: Apply through the Manak Online portal with product details, IS 16011:2012 reference, and manufacturing information.
- Testing Readiness: Ensure availability of testing facilities for pin hole count, thickness, strength, and sealing properties as per IS 16011:2012.
- Factory Inspection: BIS officials verify manufacturing process, quality control systems, and testing infrastructure.
- Sample Testing: Samples are tested at BIS-recognized laboratories to confirm compliance with IS 16011:2012.
- Grant of BIS License: Upon successful compliance, BIS grants the Certification Marks License (CM/L) allowing use of the ISI Mark.
Requirements to Obtain BIS ISI License for Aluminium Foil for Pharmaceutical Packaging (IS 16011:2012)
- Compliance of aluminium foil with IS 16011:2012 requirements including thickness, strength, and surface quality.
- Availability of testing facilities for pin hole count, thickness, bursting strength, sealing strength, and peel strength.
- Appointment of qualified quality control personnel responsible for monitoring production and testing processes.
- Implementation of the Scheme of Inspection and Testing (SIT) prescribed by BIS for consistent product quality.
To obtain BIS ISI certification for aluminium foil under Product Certification Scheme-I, manufacturers are required to submit documents categorized as follows:
- Administrative Details: Business registration, factory address proof, GST registration, and statutory approvals.
- Technical Details: Foil thickness specifications, coating/lamination details, material composition, and test parameters.
- Quality Control Personnel Details: Qualification and experience of inspection and testing personnel.
- Commercial Details: Brand name, trademark (if applicable), and authorization documents.
Cost of BIS ISI Certification for Aluminium Foil (IS 16011:2012)
The following are indicative statutory charges involved in obtaining BIS ISI certification under Scheme-I.
| S. No. | Particular | Amount (INR) | Remarks |
|---|---|---|---|
| 1 | Application Fee | ₹1,000 | Payable to BIS |
| 2 | Inspection / Audit Fee | ₹7,000 | Payable to BIS |
| 3 | Product Testing Fee | As applicable | Depends on laboratory testing |
| 4 | Marking Fee | As per actual | As per BIS norms |
Note: Fees are indicative and subject to revision by BIS. Please verify from the official BIS portal.
Benefits of Getting ISI Mark Certification for Aluminium Foil (IS 16011:2012)
BIS ISI certification ensures that aluminium foil used in pharmaceutical packaging meets safety, hygiene, and quality requirements.
1. Mandatory Compliance
Certification is mandatory for pharmaceutical packaging foil as per applicable Quality Control Orders.
2. Ensures Product Safety
Protects medicines from contamination, moisture, and environmental exposure.
3. Reliable Packaging Performance
Ensures proper sealing strength, durability, and packaging integrity.
4. Enhanced Market Credibility
ISI mark increases trust among pharmaceutical manufacturers and buyers.
5. Regulatory Acceptance
Required for supplying products to regulated pharmaceutical markets.
Frequently Asked Questions (FAQs) – BIS ISI Certification for Aluminium Foil (IS 16011:2012)
1. Is BIS certification mandatory for aluminium foil used in pharmaceutical packaging?
Yes, BIS ISI certification is mandatory as per applicable Quality Control Orders.
2. What thickness is covered under IS 16011:2012?
The standard typically covers foil thickness ranging from 20 µm to 40 µm.
3. What tests are conducted for aluminium foil?
Tests include pin hole count, thickness, bursting strength, sealing strength, peel strength, and defect inspection.
4. How long does certification take?
The process generally takes around 30–45 days depending on testing and inspection timelines.
5. Can uncertified foil be sold in India?
Products notified under mandatory certification cannot be manufactured, imported, or sold without BIS approval.
