(C) If the specimen could puncture the primary container, the primary container shall be placed within a secondary container which is puncture-resistant in addition to the above characteristics.
(B) If outside contamination of the primary container occurs, the primary container shall be placed within a second container which prevents leakage during handling, processing, storage, transport, or shipping and is labeled or color-coded according to the requirements of this standard.
We suggest CCS risk assessment should extend beyond the primary container to address a wide range of safety, economic, social, political and engineering issues.
While the size and type of a vaccine container (i.e., primary container) can have many implications on the safety and convenience of a vaccination session, another important but potentially overlooked consideration is how the design of the primary container may affect the distribution of the vaccine, its resulting cost, and whether the vial is ultimately opened.
In addition, it is also shown that a high concentration, liquid dosage form of a human monoclonal antibody is stable upon exposure to the ambient light conditions encountered during routine manufacturing, long-term storage, and administration with proper design of formulation conditions, the primary container as well as the secondary package.
One of the early testers of Grafeas is Shopify, which currently builds about 6,000 containers per day and which keeps 330,000 images in its primary container registry.
STB is defined as "the amount of time (e.g. time out of refrigeration (TOR), time at a given temperature) a drug product in the primary container can spend, outside of registered label conditions without risk to patients and product shelf life".
Primary Container Framework on Prezi.
"The size and type of primary container in which vaccines are made available to low-income countries have important implications for immunization programs in terms of safety, logistics and human resources.
International Air Transport Association IATAA) regulations require that specimens be placed in a primary receptacle, i.e. a blood tube or a screw-capped bottle, surrounded by sufficient absorbent material (such as cotton wool) so that in the event of breakage the fluid contents of the primary container will be retained within the secondary packaging.
