8.17.1. Procedure for CD Manufacturing

Aseptic Department should order a minimum number of vials as a shortened expiry date must be given to the manufactured syringes producing either single syringes or packs - specific to the number of syringes which can be made from one ampoule, for example, 18 syringes from 1 amp.

Aseptic Department must order stock from the Pharmacy Stores at Ninewells via a CD Order Book, ordering a minimum number of ampoules. These vials should be transferred via normal CD transfer process. When accepted into Aseptic, these must be recorded into the CD Register. The Envopak serial number must be recorded. The Aseptic CD Register must contain separate pages for the stock in and for those syringes manufactured within the Department (the relevant pages should be stated on the Index on the front page of the CD Register). Pharmacy Stores must also have a new page created in their CD Register for the manufactured syringes for dispensing to palliative care Wards.

Volume lost during the manufacturing should be recorded in the CD Register also. The loss could be recorded underneath the number of syringes produced to ensure that the total volume, for example 10ml has been broken down into 0.4ml syringes, therefore, on that page, we would see number of syringes + loss = 10ml.

A 0.78L blue lidded pharmaceutical waste container is used for the used ampoule and discarded volume. The white part of the lid will not be clicked into place at the time of removal from the isolator, but pulled over as far as possible, passed through the hatch into the Prep Room where the Vernagel will be added. Once the Vernagel has been added, the bin should be completely sealed (white part clicked into place) and then the bin be shaken to activate the Vernagel.

Wards will order CDs as per their normal process and Stores will dispense accordingly. ​Pharmacy Stores will transfer stock to the requesting Wards accordingly. Wards will not order directly to the Aseptic Department.

CD Transfer Form Sheet to Pharmacy Stores must be used for the manufactured syringes being accepted into Pharmacy Stores.