Seal integrity

D devices have complex requirements on assembly and, in particular, sealing. Integration of sensing is not as facile as for chip micro reactors. In turn, 3-D devices are robust and comprise the classical materials for chemical engineering apparatus. 

It is recognized that physical and mechanical properties of a parenteral system affect seal integrity. However, physical and/or microbiological testing approaches may be used to challenge seal integrity or demonstrate that a seal has been achieved and is being maintained over the shelf life of the container system. 

ETO and degradation product toxicity Impact on seal integrity... 

Grips, handles, feet, pads for small electrical machines. .. Seals, integrated seals... 

Another essential area is the testing of the seal integrity of the closure. 

Additional physical tests, such as frame memory, resiliency, tensile strength, and seal integrity. 

Physical considerations such as water vapor transmission to evaluate seal integrity, thermal analysis such as DSC to monitor melting point and glass transitions of plastics, and IR scanning to prove identity should be part of an ongoing quality control monitoring program. 

Ethylene may be copolymerised with vinyl acetate to make ethyl-vinyl acetate, offering high seal integrity and clarity for frozen food applications where a high degree of toughness is required. Ethylene copolymers with other olefins such as propylene, 1-hexene and 1-octene allow a range of properties to be achieved. Linear low density polyethylene (LLDPE) has a... 

Crist [37] studied lyophilized pharmaceuticals sealed under reduced pressure and demonstrated that vial pressure is primarily due to desorption of water vapor from the stopper into the head space of the vial. The presence of a hydrophilic product decreases the rate of pressure rise, and pressure increases more rapidly in smaller vials. Results are discussed in terms of testing for seal integrity and for stopper effects on moisture in the product. 

The first set of requirements that closures for lyophilized product containers must meet are those described for stoppers used in containers for parenteral drugs. They must serve as a barrier to microbial contamination, be compatible with the formulated drug product, and not leach out toxic materials. They must be tested in the prescribed manner for seal integrity and product capability. The reader is referred to sections in the United States, European, and Japanese pharmacopoeias for appropriate test methods for evaluating extractables. 

As with the single check valve, the effectiveness of double check valves depends entirely on their sealing integrity. Should the seals develop leaks, undetected backflow could occur. For this reason, double check valves should only be used where backflow could be objectionable—but not hazardous—and should never be used where backflow could cause a potential health hazard or other serious condition. 

Individual foil packets are tested for proper sealing. Several methods of rapid seal integrity testing have been devised, such as the vacuum underwater method, detection of tracer material sealed within the pouch, purging with detectable gas, IR seal inspection, and electronic air-tightness testers. ... 

Compression set is commonly used as a measure of the dimensional recovery of a rubber compound after compression at a defined level, usually 25%, at a specified time and temperature, usually 24 h at 70°C. High compression set values are associated with rubber that takes a set or loses its ability to spring back after compression. Low compression set is important for rubber closures and syringe plungers that are heat sterilized while under compression and remain under compression for long periods of time before use but must remain elastic and resilient to maintain seal integrity. Compression Set is measured on dimensionally defined test specimens. 

Pre-cretaceous top-seal integrity in the greater Ekofisk area... 

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