A former Engineering Manager for a leading pharmaceutical company recounts his experience in establishing a new cleanroom dispensary facility. Mr Tony Blair has extensive experience in this field and tells the story of an installation of Vilair-AAF equipment.
‘The company’s Sydney plant was already a regular user of specialised Vilair air filtration media. We needed to significantly expand our output of solid dose pharmaceutical products to meet increased domestic and export requirements. The existing dispensary facility was too small to handle the increased demand. Although capable of satisfying the Therapeutic Goods Administration’s former code of Good Manufacturing Practice for clean room installations, it was unlikely that the facility would meet the revised TGA and European Union cGMP requirements. It was also necessary in the interests of OH&S to eliminate the exposure of dispensary personnel to potentially hazardous pharmaceutical ingredients in powder form. ‘I was given a brief to have a new dispensary facility built within the existing building envelope that would satisfy AS 1386 Class 350 as well as the new TGA and EU cGMP requirements. At the same time, all OH&S and environmental concerns had to be addressed and satisfied. In other words, it had to be a ‘state-of-the-art’ facility that would satisfy the company’s needs into the future. ‘One complicating factor was that the proposed installation was immediately adjacent to the existing production area. Access to the work site could not pass through or otherwise impinge on existing manufacturing operations. We drew up a Site Plan, Design Qualification (specification) and Validation Documentation that specified number of air changes, vectored air velocity and pressure gradients, filtration grades, particle counts, lighting and sound levels, surface finishes and HVAC airflow temperature & humidity conditions. Validation of the end product was also required.
We then commenced a search to see if we could find a company to supply & validate the installation; and be prepared to guarantee its future performance. ‘Two companies that could have met these requirements in the past were in a state of flux; and their future performance could not be guaranteed. A third company was prepared to import a unit but the cost was likely to be three times that of a locally-built unit. I thought it would be impossible to find a company that could supply our needs, meet our very exacting specification, provide validation and guarantee performance now and in the future. ‘When I approached Vilair-AAF for assistance, their staff advised that they could build the clean room and meet the specification. We were initially sceptical of these claims because Vilair-AAF had not built such a facility in the past – although some of its personnel had been involved in major cleanroom projects. After meetings with their management and their sub-contractors who would be involved in the project; dissecting the specification and examining their qualifications and preliminary designs, I was convinced that they could do the job. An order was subsequently placed with Vilair-AAF to carry out the work. ‘I specified that the room envelope be constructed with walls and ceiling built in white Colorbond steel-faced sandwich panel. In the dust containment booth area, the sandwich panel walls were faced with 2B-finish 304 stainless steel. All wall and floor junctions were fitted with 50 mm aluminium coving and all joints were sealed with a mould-resistant elastomer. The concrete floor had a trowelled-on self-levelling epoxy finish that was sealed with a clear polyurethane finish. To ensure separation of the new dispensary area from the adjacent production and compounding areas, a PVC rapid-roll door was installed at the entrance. An additional glazed automatic aluminium sliding door was fitted across the entrance to the access corridor to ensure the correct air pressure differential would be maintained at the entrance to the dispensary.
‘The HVAC contractor, in liaison with Vilair-AAF, installed the air-conditioning fan/coil unit, supply and return-air ductwork and HEPA filtration systems in the ceiling void with the condenser unit being externally mounted on the roof Vilair-AAF’s installation team then installed the stainless steel faced exhaust housing, the variable-speed exhaust fans, the 2-stage G4 & F7 grade prefilters and fan-assisted H14 HEPA modules. The H14 HEPA filters were mounted in the stainless steel ceiling between rows of twin-tube 38 W sealed fluorescent light fittings. These produced lighting level in the booth > 800 lux. Compartments were built into the face of the booth fascia to house a computer tower, keyboard, LCD monitor, inkjet printer, label printer and electrical controls. Magnehelic gauges were installed in the fascia to indicate filter condition and RS232 outlets were provided on the face panel for a digital weighing scale. A perforated stainless steel work bench was fitted to the fascia as a scale mounting (to minimise air turbulence) and all prefilters were behind stainless steel screens. ‘After all works were completed Vilair-AAF’s validation contractor carried out the necessary tests and provided the NATA certification as specified in the validation documentation. At completion and hand-over, I commented that it was indeed a pleasure to see such excellent workmanship carried out so expeditiously to produce an installation that not only satisfied all the specified requirements, but was of ‘world-class’ standard. When the room and the laminar flow booth were put into operation, plant personnel stated that they could not believe they would be working in such excellent conditions. One could say ‘Testimony enough to the quality of the installation!’