Why SIMS 1915+ is a Practical Solution for Testing Blister Packs?


Blister packs are often used as unit-dose packaging for pharmaceutical tablets, capsules, and other similar products. A cavity or pocket made of a formable film, commonly a cold-formed aluminum film, is the primary component of a blister pack. The use of aluminum provides a perfect barrier against moisture, light, and oxygen. Blister packing has the following major advantages: 

The medicine can be stored in a stable and reliable condition. 

  • A small amount and serial packing can be easily realized. 
  • The packaging is secure, hygienic, portable, and convenient. 
  • It has a high degree of flexibility and long shelf life. 
Blister packaging uses a variety of plastic materials such as polyvinyl chloride (PVC), polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), high-density polyethylene (HDPE), and aluminum sheets or foils. Blister packaging can provide barrier protection as well as some tamper resistance to meet shelf-life requirements. On the other hand, the rising demand for cold-form blister packs has increased concerns regarding blister package integrity. Therefore, pharmaceutical manufacturers use various leak detection technologies to ensure that the integrity of the blister packs is not compromised.   

Ensuring the Integrity of Blister Packs Using SIMS 1915+ 

Seal Integrity Monitoring System (SIMS) 1915+, a helium leak detection technology, is a commonly used technique for testing leaks in blister packs. Packages may be quantitatively evaluated using helium as the tracer gas, which assures better levels of accuracy when compared to traditional vacuum bubble and dye penetration test procedures. This method enables a comparison of different packaging materials and forms, as well as production line settings and stable storage conditions. SIMS 1915+ provides a wide range of applications, including package design, tooling qualification, manufacturing line setup, and ongoing product quality monitoring.  

SIMS 1915+ is equipped with an oil-free pump, detector, and integrated power system. The Helium Leak Detector Module (HLDM), the most crucial component, is built within a Console Frame Assembly with a Stainless Steel working surface and an optional Dual Test Port Manifold. The consoles have a locking wheel and an articulating arm system for attaching the computer and peripherals, making the independent device simple to operate and maneuver. 

 

Each SIMS 1915+ helium leak testing device is custom manufactured to meet the specifications and packaging configurations of the client. SIMS 1915+ enables an analysis of packages at low sensitivity level up to  1 x 10-10 mbar/L/sec and provides relevant data sets in place of simple pass/fail criteria. It can accommodate several package types, such as foil pouches, parenteral vials, syringes, and unique medical device equipment. 


SIMS 1915+ Options 

  • Low-Temperature Add-on Systems (LT 80 and LT 150) for ultra-cold CCI testing utilizing helium leak detection methods. 
  • Vacuum test fixtures are available in a range of sizes to accommodate all package types and sizes. 
  • External helium leak standards are available in a number of leak rate ranges. 
  • Helium Sniffer Probe - used to pinpoint leak sites on a site-by-site basis. 
  • Vacuum clamps, O-ring seals, chamber gaskets, etc. 
  • Custom test fixtures are used for helium leak testing in non-vacuum chamber applications. 

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