Glass containers, parenteral drug

Glass containers for small volume parenteral products Factors for selection and test methods for identification. Parenteral Drug Association Inc., Technical Methods Bulletin No. 3, 1982. 

Type I glass containers comprise a borosilicate glass with about 80% Si02 and 10% B2O3 and smaller amounts of AI2O3 and Na20. It is inert and has the lowest coefficient of thermal expansion. It is least likely to crack when a sudden temperature differential occurs. It is commonly used to make ampuls and vials for parenteral use. It is used for solutions that can dissolve basic oxides to cause an increase in pH that could alter the efficacy or potency of the drug. " ... 

One of the major drawbacks to the use of plastics is their heat intolerance. Because many plastics will melt or degrade at high temperatures, they are not well-suited to sterile applications. Parenteral drugs in particular require guaranteed sterility, and often this sterility can best be provided by glass containers. 

Due to the need to check for particles, fibers, and possible discoloration in drug solutions transparent and colorless packaging materials are desirable. Hence, uncolored glass and plastic, bottles and bags, are commonly used as primary packaging for parenteral. To attain photo protection without losing VIS controllability, transparent containers or covers are necessary. 

In busy hospital wards, the nursing staff often removes the outer cartons from parenteral products, and the preparations are stored without any protection against optical irradiation. In addition, ex tempore preparations are produced in the hospital pharmacy without outer protection and not usually protected when distributed to the wards (e.g., by use of aluminum foil) unless specifically instructed. According to the European Pharmacopoeia (2002), containers for parenteral preparations are to be made when possible from materials (usually glass or plastic materials) that are sufficiently transparent to permit visual inspection of the contents. As a consequence, the containers will offer no protection, or in some cases only limited protection, against photochemical decomposition of the drug substance or the formulation. 

---