The Buck Systems range of modular dispensing solutions provide for simple ergonomic operation whilst ensuring control of the dispensing process.
The control system interlocks the process with the recipe management system to provide batch data security and traceability for validation purposes. Additional features such as removable hoppers and additional extraction provide increased safety for operators and simplicity for cleaning. Solutions range from single level for simple applications to multiple level, integrated dispensary management systems. Bulk ingredient dispensing includes fully automated excipient dosing or interfacing with big-bag bulk ingredients for high containment.
API (Active Pharmaceutical Ingredient) can be dispensed into a contained charge vessel, which can then be safely transported to the point of use within the plant.
Dispensaries - understanding your process
As a key part of any pharmaceutical processing plant, the dispensing area presents many challenges. In particular, it is important to establish a clear understanding of both existing processes and products, and future requirements as far as possible. Buck’s approach to some of the key issues for a dispensary within a production based plant can be summarised as follows :-
A dispensary can take many forms: single or multi level, low or high containment levels, commonly incorporating two to four weigh platforms, a weigh hopper, extraction equipment and sieving equipment. The dispensary may also include recipe management software, waste disposal system and a method of handling API.
Excipients and bulk ingredients arrive packaged in various forms, thus requiring differing handling methods. For small volume dispensaries or line dedicated dispensaries with a small batch size, the preferred method may be manual. However, with ever more stringent manual handling regulations, it may be necessary to add automation and mechanical handling to avoid these problems. For larger volume plants and larger batch sizes, it is essential to automate the handling. This is achieved by either simply lifting a pallet with a local stacker truck, or ideally by using a hoist lifter. The advantage of the hoist lifter is its ability to simply handle sacks, drums and bags without the additional difficulties of manoeuvring in what is often a confined area.
Dust exposure is another key consideration. This obviously depends on the types of products, local Health and Safety regulations and dispensary room design. There are several ways to approach this issue, for example as follows.
1. The traditional method is to rely solely on the room air changes and with use of operator protection such as dust masks and air hoods.
2. An alternative approach is to establish an air curtain across the inlet of the weigh hopper. This is a simple but very effective solution provided that the equipment design and extraction levels are properly integrated.
3. Another alternative is use of an extraction hood above the weigh hopper, enabling the operator to dispense ingredients within the extraction zone. This provides additional protection, thereby ensuring a high level of safety, in a cost effective manner.
4. Extraction booths and laminar flow booths are also often used, sometimes in conjunction with the above solutions, to create an additional airflow away from the operator. This extra protection offers improved flexibility in the working area, although special airflow patterns may be required to ensure safe airflow is achieved around the weigh hopper and any other equipment within the booth.
5. For toxic materials, an isolator may be required, however the number of isolators should be limited due to the comparatively high capital and operating expenses. The use of contained charge vessels can significantly reduce the requirement for isolators, especially when
incorporated in the process plant design.
The weigh system typically includes a bench top scale, floor scale and load cells on the dispensing hopper. In addition there may be a weigh frame for ‘check weigh’ purposes. The weigh frame may be located on the same level, or ideally, when charging Intermediate Bulk Containers (IBC system), on the floor level below. When filling the IBC on the lower level, it is also possible to integrate the weigh frame into a post hoist to lift and dock at ceiling height,
although this can reduce system accuracy.
Sieving is common requirement and must be incorporated in the design of the dispensary to ensure that suitable air flows and dispensary ergonomics are achieved.
The API can be handled in several ways depending on the containment level recommended by the plant Occupational Hygienist. For example, transferring the required quantity of API into a contained charge vessel within an extraction booth or dedicated isolator as mentioned above. This charge vessel, incorporating a Buck® split valve technology can be manually moved safely around the plant to enabling the API to be safely used at the ‘point of use’. Furthermore, ideally the API can be transferred into a contained charge vessel at the primary production plant, already prepared for dispensing at the point of use, or for contained dosing, negating the need for an isolator.
Recipe management can be achieved in several ways; a paper driven system requiring the operator to record all weigh dispensing operations, a simple recipe display driven and paper based system, or a full SCADA driven system guiding the operator through all key stages ensuring complete control and batch data security in accordance with 21 CFR part 11 – Electronic Signatures and Records. It is essential that a dispensary control system is practical for the operator, e.g. use of bar code scanner with intelligent hand held displays to assist in inventory management, limiting operator intensive tasks and improving production efficiency.
Buck Systems will normally supply the dispensary system as an integrated package with the specification and design incorporating key issues such as: interchangeable weigh hoppers, batch data security and traceability, ease of maintenance, cleanability, building and utility requirements, and all process requirements.