PRESS RELEASE 7 July 2008
Ci-DMS Assists The Drive Towards
Pharmaceutical Containment
CI Systems has introduced a new module to its Ci-DMS dispensary management suite to allow multiple materials to be added into a single container. When addition occurs within a down flow booth this module also assists pharmaceutical companies in their drive towards containment within the production area.
Pharmaceutical Containment Area
Typical applications include the filling of mobile IBCs (intermediate bulk containers) positioned on load cells where bulk ingredients can be added directly into the IBC while the smaller quantity ingredients can be weighed on a second balance and subsequently added into the IBC.
Ci-DMS is a configurable product capable of working with many different physical layouts and material addition requirements. It can be easily configured such that bulk materials can be added directly into granulators, mixing vessels or ribbon blenders via a charging hopper. In the same configuration active material can be added directly into the vessel, having previously been manually dispensed to within tolerance.
A charging hopper can be configured such that it is designated as having load cells or not. The charging hopper operation can be controlled by the Ci-DMS, including operation of any automatic locking devices and, if applicable, an associated vacuum conveying system to pneumatically empty the charging hopper when filled. Ci-DMS can be configured to control which addition point each ingredient is to be added through and the sequence of addition.
As with the other modules in the Ci-DMS suite the fully configurable manual addition helps to avoid errors and assists in maintaining full traceability of pharmaceutical products. It comes with comprehensive security and audit trails and conforms to the requirements of the FDA's 21CFR part 11 for electronic records and electronic signatures. In addition, a material may not be added until the operator has acknowledged the relevant health and safety warnings. It also maintains comprehensive cleaning records including validation of the cleanliness of the IBC/vessel to which the material is to be added.
When integrated with ERP (Enterprise Resource Planning) software, such as SAP or JD Edwards, the Ci-DMS suite can receive a works order and instruct the operator through the batch manufacturing process applicable to the installation (maintaining comprehensive records as required). Using this easily integrated interface, stock levels can be revised automatically, the product's progress through the manufacturing process can be tracked and the individual IBCs' status can be recorded and their histories updated.
Designed according to GAMP guidelines Ci-DMS is supplied with comprehensive validation support documentation allowing validation of the system to the standards required by the industry's regulators.
For more information or to discuss a particular application, telephone 01722 424100
or email sales@cielec.com
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