14/12/2010Integrating Ergonomic Trials Into The Design Process

Containment involves separating production operators from the potential hazards of the material being handled, necessitating close attention at the design stage to the human aspects of the process which is to be carried out. Getting to know the process is the key.  Evaluating the process containment ergonomic issues and understanding the process equipment operation are all critical elements to success, which contributes to ensure the most effective work processes and end results for the client.  In fact, a leading pharmaceutical company report stated almost 25% of all lost time illnesses were caused by ergonomic related issues.

Telstar ACE put great emphasis on the need to perform ergonomic trials, at the onset of all projects to identify issues and prevent them becoming a problem. These models together with trials serve to simulate the process operations involved in a recently awarded project.

This particular aseptic process is for the freeze-drying and final packing of bulk sterile cephalosporine and includes various process equipment, RABs and isolator units to provide the ISO class 5 environment required for such a process.

The importance of Ergonomic evaluation can not be stressed enough and it is a fact that the benefits are both time and cost saving, for the client in the long term. In addition the need for operatives to be involved, will ensure that all parties buy in to the investment of 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 and P & ID drawings of the unit(s), from which mutual agreement is made with the client, usually based on the URS document, and agreed specification.

The Ergonomic model is produced utilising HT Timber and Polycarbonate materials, to simulate the accurate sizes of the unit(s), with added features of Gloveports, Transfer ports and Wash facilities fitted using actual equipment which will be fitted to the finished units.

The client and representatives are brought along to the TelstarACE factory; or alternatively the model is taken to the client site; where a pre-agreed Ergonomic report document forms the basis for the trials. Consideration is taken to the key access area's 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.

The Gloveport position and size is 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, whilst maintaining a comfortable posture. The position of the controls or 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.

We will always recommend to client's, existing and new that the benefits of an Ergonomic review are invaluable and have to be a prime concern for the well being of the operators during process activities, which is a value to the client at all times.

Article written by Steve Sweryda. General Manager. Telstar ACE, Technology Centre for Containment Systems.