Coring of a medication vial’s rubber stopper has been reported as a major cause of visible particle presence in injectable preparations. In this study, we investigated and quantified visible particle formation caused by coring associated with four potenti

The factors studied were: nature of the rubber stopper; rubber stopper thickness, type of metal needle bevel used to pierce the stopper, and puncture technique. For each one of 16 different situations, 40 medication vial rubber stoppers were punctured, an

The incidence of particle formation ranged from 0 % to 75 %, depending on the situation. Particle length was on average of 0.98±0.39 mm. The situation that gave the most particles (75 %; 30/40) was obtained when using a short bevelled needle, a 4 mm thick

Rubber stoppers allow easy access to drugs contained in glass medication vials, as they can be readily punctured through with a needle or a cannula. In hospitals in general and in intensive care units in particular, the great use of injectable drugs packa

Clinical risks induced by intravenous administration of visible particulate matter are still incompletely characterised or documented, yet macroscopic particles have been incriminated as being able to cause phlebitis and venous inflammatory reactions [9],

In order to test two different types of rubber (made from bromobutyl or chlorobutyl elastomer), with two different thicknesses (measured at the centre of the stopper), and two different needle bevels, the following commercially available products were pur

For each one of the 16 situations, the following protocol was applied by one investigator, who performed solely the manipulations to ensure reproducibility, with n=40 vials per situation: each vial’s stopper was punctured once with a new needle in accorda

The contents of each vial was then emptied (after having manually removed the stopper) and filtered under vacuum through a 0.45 µm filter (10 vials of the same situation per filter, and 4 filters per situation, for a total of 40 vials per situation). The

Coring is when a small piece of a vial’s rubber stopper breaks off and contaminates the contents of a sterile vial. It can typically be noticed floating on top of or inside the medication or stuck to the inside wall of the vial. This small foreign body ca

Medications should be drawn up in a designated clean medication preparation area that is not adjacent to potential sources of contamination, including sinks or other water sources. Water can splash or spread as droplets more than a meter from a sink. In a

The medication preparation area should be cleaned and disinfected on a regular basis, and any time there is evidence of soiling. In addition, there should be ready access to necessary supplies (such as alcohol-based hand rub, needles and syringes in their

From an infection control perspective, the safest practice is to prepare an injection as close as possible to the time of administration to the patient. This is to prevent compromised sterility (i.e., microbial contamination or proliferation) or compromis

Proper hand hygiene should be performed before handling medications, and the rubber septum should be disinfected with 70% isopropyl alcohol prior to piercing it and allow the alcohol to dry. To prevent coring, the needle should be inserted at a 45–60° an

To prevent vacuum formation, inject air into the vial equal to the volume to be withdrawn. When reconstituting a powdered drug, withdraw a volume of air equal to the amount of the diluent to be added. This will prevent positive pressure from developing in

The rubber stopper is of the highest quality level and is produced under secured and certified process conditions in accordance with the applicable guidelines. In the standard range, you will find the most common models of stoppers for injection vials, in

All rubber stoppers are stored in and supplied from our ISO certified warehouse in Uithoorn. The storage, forwarding and delivery of the rubber stoppers takes place under conditions that are consistent with the pharmaceutical guidelines and Good Distribut