ISI Certification (BIS) for ALUMINIUM FOIL FOR PHARMACEUTICAL PACKAGING IS 16011

BIS CERTIFICATION OF ALUMINIUM FOIL FOR PHARMACEUTICAL PACKAGING IS 16011

1.   Introduction to Indian Standard IS 16011; Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging  

·       IS 16011 cover Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging. This standard specifies the manufacturing, chemical and physical requirements and testing of Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging.

·       The material used shall conform to the chemical composition of the Grades 19000, 19500, 19600, 31000 or 40800 of IS 737.

·       IS 16011 specifies the quality parameters or characteristics of the Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging  as follows

(i)           Pin hole count

(ii)         Average Thickness of Bare Foil

(iii)        Freedom from defects

(iv)        Coating / Lamination

(v)          Width

(vi)        Bursting Strength

(vii)       Peel Strength

(viii)     Sealing Strength

(ix)        Lubricants

2.   Mandate for ISI Mark Certification of Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging  (IS 16011) :

·       Under section 14 of Bureau of Indian Standards Act, 1986 (63 of 1986), the Ministry of Commerce and Industry, Department for Promotion of Industry and Internal Trade after consulting the Bureau of Indian Standards has issued the Quality control order.

·       As per the Quality control order, all the manufacturers of Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging are obligated to obtain ISI Mark Certification.

3.  Types of Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging  covered under IS                    

4.   Procedure to obtain BIS Certification of Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging to use ISI mark as per IS 16011

·       For Indian Manufacturers (Standard Timeframe – 30 days)

·       For Foreign Manufacturers (Standard Timeframe – 180 days)

5.   Requisites to get the BIS license for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging

·       Conformity of Raw Material as per IS 16011

·       In-house testing laboratory for mandatory tests

·       Competent Quality Control Personnel

·       Adherence to the BIS guidelines for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging  as per Indian standard IS 16011

·       There are 3 major categories of document required to get the BIS license:

a.   Administrative Details

b.   Technical Details

c.    Quality Control Personnel Details

d.   Commercial Details

6.   Expenses involved in obtaining BIS certificate for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging as per IS 16011 under the Product Certification (Scheme-I) of BIS :

 ·     In the certification process, product testing is the most important stage as it determines whether the quality of the product meets Indian standards.

·       For the same purpose, investments in testing facilities are required to install test equipment for internal factory test laboratories.

·       Apart from charges mentioned above in the table, we may ask you to pay/reimbursement for a Pre-Visit at your Factory Premises to ensure the conformity of your product as per the relevant Indian Standard & BIS guidelines for its BIS certification.

7.   Role of ERCS Private Limited in getting your product certified :

·       To get BIS certification and produce a standard quality product, the manufacturer must ensure that their product must follow the specified Indian Standard Specifications (ISS) which we directly interpret to you from the BIS officials as per the Indian Standards.

·       ECRS Private Limited will be your friend, philosopher and guide in the whole process of getting your product certified by the concerned authorities/ departments.

·       Scope of work by ECRS Private Limited:

a.     Ensuring the conformity of your product as per IS 16011:

ERCS Pvt. Ltd. has developed a vast network within the Aluminium & Aluminum Alloy Industry various BIS departments to assist for ensuring conformity of the product Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging according to IS 16011.

b.     Effective documentation with the awareness of the BIS guidelines:

In order to facilitate the manufacturing industry in obtaining BIS certifications, guidelines have been developed. Our team has the experience of completing over 450 projects and technically competent acquaintances in various Industries.

We are familiar with the Indian Standard Specifications & BIS guidelines and deliver the most suitable interpretation to the Quality Control Personnel so we can do a reliable and effective documentation of your product in accordance with the BIS guidelines.

c.      A pre-visit can be paid at your factory premises:

In the process of getting BIS certification, the officer from BIS authority visits the factory for inspection. In order to get good results, the BIS inspection should go smoothly without any Non-Conformity. By keeping this goal in mind, our team will organize a pre-visit to your factory premises so that required changes can be adapted so as to remove the elements of fallibility.

d.     Assistance for BIS audits:

We will explain the whole procedure of conducting a BIS inspection and make you aware of the things which need to be prepared and readily available at the time of inspection.

Benefits of getting ISI Mark for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging to sell in Indian Market with our help

§  The term “ISI mark" means, that a certain product conforms to the quality standards set up by the government.

§  It is compulsory for Aluminium and Aluminium Alloy Foil for Pharmaceutical Packaging  to obtain the ISI Mark and the violators are penalized with the material seize and a significant sum as fine.

§  Getting certification improves the probability of your product to survive and compete in the market.

§  Customers have the tendency of buying ISI certified products as it ensured safety and standard quality. Hence, with the certified products you can win the confidence and trust of the buyer.

§  With the word of mouth of such client list, you can establish your credibility in the market.

§  Hence with the renowned brand, you can raise the standard and benchmark the market value of the product.