Extractable and Leachable Study

 
 
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Testing of Packaging Materials


Merck tests packaging materials for caustic soda, hydrochloric acid,  acetic acid and highly purified water.

In a 12-month study, Merck tested how popular packagings for GMP-manufactured CIP and process solutions perform in terms of inorganic extractables and organic leachables. This is an important topic for customers who demand purity at the point of use for critical tasks – for instance, when cleaning chromatography resins and filters in downstream. As the results show, our customers can work with complete confidence.

What We Tested
During the rigorous test, we examined how 25 L fluorinated PE canisters, 200 L PE drums and 950 L IBCs responded to highly concentrated solutions of three of our most popular solutions – caustic soda, hydrochloric acid and acetic acid –, as well as highly purified water. All containers were FDA approved, and were stored at 40°C to create a worst-case scenario in terms of extractables.

How We Tested 
Inorganic extractables were measured by ICP-MS and GF-AAS; organic leachables were analyzed by GC-FID. During chromatographic analysis, toluene was used for extraction. Both the toluene extracts of the samples and the toluene extracts of the neutralized acids and leaches were measured.

Results
The polyethylene* used as a primary packaging material can be considered suitable for all tested products. Inorganic extractables were below the detection limits of the respective analytical methods. The identities of all peaks that exceeded quantification limits in GC-FID were confirmed by means of additional tests (HPLC-MS and GC-MS).

The total concentration of all detected organic leachables corresponded to the detection limit of the internal standard, and was < 2 µg ml-1 or < 0.2 µg ml-1.

Click here to view the test report in full.

 

*(fluorinated polyethylene for acetic acid)



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