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The latest in pharmaceutical leak detection

What is better than having a completely automatic in-line leak testing system, being 100% reliable and repeatable, and most of all fully validated!!

Leak detection and measurement is currently the subject of ever-increasing attention by legislative bodies (environmental, health, etc.). This is resulting in more stringent and definitive standards and specifications.

A quality control department, therefore, must be aware of different testing methodologies in order to gain this control and assurance over production and packaging processes.

Historically, leak testing in the pharmaceutical industry has always involved some form of sample testing using the blue dye methodology. This type of test has the relatively simple goal of determining whether a package/container leaks or not, by watching if the blue dye penetrates into the sealed container. This test, even though widely used, is time consuming, destructive and therefore cannot be a 100% test. Leak testing has moved one step ahead with the method of vacuum decay. Below are the main differences between the 2 methods:

 

Bonfiglioli Pharma Machinery is a division of Bonfiglioli Engineering, a world-wide leader in the development and in the continuous research of automated machines for non-destructive leak testing of any type of container in various fields such as metal, plastic, food industry etc. having the requirements for a perfect seal integrity. Since 1974 our company has gained an excellent reputation world-wide.

The inspection systems are studied in the minimum details and developed in order to meet any requirement of non-destructive testing of any kind of package, in particular such machinery are designed to test all the pharmaceutical containers such as vials, glass and plastic vials, ampoules, blister packs, BFS monodose, plastic strip, pouch containing IV solutions etc, at any production speed that is required.

The technical features adopted have the following targets: reliability, testing precision, speed, repeatability, silence, user friendliness, cleaning and maintenance simplicity, and low energy consumption.

The complete range of these automated machines is composed of laboratory machines that can be located in the Quality Control Department and of rotary machines that can be installed, with ease and complete functionality in your production lines.

The micro-leak test is carried out using the absolute pressure decay method; it is extremely reliable since the test is managed by means of a data acquisition system and data processing controlled by a microprocessor. This accuracy fits to the pharmaceutical field, where producers need to supply the market with a safe product and therefore impacts directly on their marketing image. Moreover test is guaranteed by a user-friendly operator interface and real-time results.

Our leak testing systems are completed with documentation supporting the qualification in Validation protocol in the total coherence with the FDA guidelines.

Click here to download World Pharmaceutical Frontiers Magazine Feature on Leak Testing from Bonfiglioli.

 

CONTACT INFORMATION

TASI Group: Bonfiglioli Engineering and Sepha

Via Rondona 33

Vigarano Pieve (FE), 44049

ITALY

Phone: +39 0532 715 631

Fax: 00 39 05 32 71 56 25

Contact: Sergio Bonsi

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