Isolators are designed for containment; however, Steve Sweryda, general manager, Telstar ACE, argues that the integration of ergonomic trials into the design process is key to ensuring their usability
Containment involves separating production operators from the potential hazards of the material being handled. This necessitates close attention at the design stage to the human aspects of the process that is to be carried out. In fact, a leading pharmaceutical company report stated that almost 25% of all lost-time illnesses were caused by ergonomics-related issues.
Getting to know the process is the key. Evaluating the ergonomic issues associated with process containment and understanding the process equipment operation are critical elements to success, which contribute to ensuring the most effective work processes and end results for the client.
Telstar ACE puts great emphasis on the need to perform ergonomic trials, at the outset of all projects to identify issues and prevent them becoming a problem. In a recently awarded project, ergonomic models were produced that, together with trials, serve to simulate the process operations involved.
This particular aseptic process was for the freeze-drying and final packing of bulk sterile cephalosporine and included various items of process equipment, RABs and isolator units to provide the ISO Class 5 environment required for such a process.
The importance of ergonomic evaluation cannot be stressed enough and the benefits are both time- and cost-savings for the client in the long term. In addition, involving the operatives will ensure that all parties buy in to the investment in new equipment, and ensure the longevity of the project. The operator and maintenance team are the people who will ultimately be responsible for the smooth running of the units, and production or development of process associated with the equipment.
The process begins with a GA (General Arrangement) and P & ID (Piping and instrumentation diagram) drawings of the units, from which mutual agreement is reached with the client, usually based on the agreed User Requirements Specification (URS).
The ergonomic model is produced utilising high tensile timber and polycarbonate materials to simulate the accurate size of the units, with added features of gloveports, transfer ports and wash facilities fitted using actual equipment that will be fitted to the finished units.
The client and representatives either come to the Telstar ACE factory or the model is taken to the client site, where a pre-agreed ergonomic report document forms the basis for the trials. Consideration is given to the key access areas and reach of process requirements, ensuring that all activities and process can be achieved without undue difficulties to the operators.
All connections and lifting activities within the unit are considered and either agreed or amended during the trials to accommodate the needs of the operators and activities of process within the unit. Where any major modifications are required, the model is changed quickly and with the client’s input, changes are accommodated there and then to avoid any unnecessary delays during the trials. The changes may involve a larger chamber or pass box, position of utility connections or storage trays access for handling of internal equipment in the unit.
Lines of visibility
The gloveport position and size are among the most important considerations to give full access to the operators, as well as clear vision through the glazing panel for viewing of the internal process, while maintaining a comfortable posture. The position of the controls or human machine interface (HMI) is essential for operators, as is the viewing of the filter gauges and possible instrumentation reading for O2 monitoring or N2 purge facilities. These are all simulated on the ergonomic model by full-size simulation and printing of the instrument panels and gauges.
The frequency of operation and duration of the operations will have an effect on the operator, which has to be sustainable during operations and activities within the glovebox.
Ultimately it is the client who will determine and finally agree the position of amenities on the unit, with the approval and sign-off on the report protocol, to enable the detail to be finalised and commence manufacture. It goes without saying that once the manufacture is complete, any changes not captured by an ergonomic review are extremely expensive and time-consuming, which is a major problem at a late stage.
The outcome of an ergonomic review is a satisfactory agreement between vendor and client to achieve the optimum operating procedure for the glovebox, in a timely and efficient manner and avoiding surprise changes down the line.
Telstar ACE believes that the benefits of an ergonomic review are invaluable and should be a prime concern for the well being of the operators during process activities.