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| Kilo Lab |
| The Kilo-Lab facility
was installed in 2004 to bridge the gap in capacity between
laboratory and Pilot Plant and to provide the means for offering
manufacture of smaller volume high-value added products. In
particular, the facility was designed with the developmental
and preclinical needs of the pharmaceutical industry in mind. |
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| The unit is housed separately
from the laboratory but close enough to our Pilot Plant to access
all of the Pilot Plant facilities, such as scrubbers and abatement
and vacuum. The facility is operated in accordance with ISO
standards; the objective being to provide early phase
trial materials on minimum lead times with more flexibility
and at less cost than equivalent fully GMP units. |
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| Kilo-Lab in Summary: |
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20 L Glass Assembly |
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Temperature range from 30 to 300°C |
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50 L Glass Assembly with Distillation. |
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5 L Fractional Distillation unit. |
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2 L Hydrogenators 3 nos. |
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Full access to Pilot Plant facilities - vacuum & abatement
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Vacuum Oven for drying low melting solids. |
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| Pilot Plant |
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| Indo Amines Ltd Pilot Plant facility is used for scale-up and development of our new products and processes as well as commercial manufacture to support our customer's smaller volume requirements. |
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| The facility consists of fully flexible reactors, available in both glass lined and stainless steel. The array of reactors gives a capacity from 50 litres up to 1000 litres. The reactors are complemented by a range of enclosed filter dryer's for solids handling with fractional and short path distillation equipment for liquids. The Pilot Plant is connected to the site ring main system meaning that the vessels are all vented to our system. |
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| Summary of Service Facilities |
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Temperature range from 35°C to 300°C |
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20 L Autoclave (Hydrogenator) working at 20 Kgs.sq inch. |
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50 L Glass Reactor with distillation assembly. |
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Distillation equipment including Short Path Distillation unit for Liquids |
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Vacuum = 1 mBar |
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200 L pilot Reactor |
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| Process Improvement & Implementation Group (PIIG) |
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A PIIG is a multidisciplinary group consisting of representatives from Production, Engineering, Quality, Research and Sales and Marketing that meets every 3-6 weeks. Every Product made at IAL has a PIIG associated with it. |
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In its infancy the PIIG may be initially a Technology Transfer Group (TTG) that implements a new process or technology into Production or the Research Pilot Plant. As the process becomes mature, the TTG develops into a PIIG and some members may leave and others may join depending on the group's requirements. |
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| A PIIG does many things |
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- Plans Production campaigns and logistics
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Reviews Production output and yields |
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Shares Customer communications |
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Review Quality and Delivery Performance and plans to meet Customer expectations |
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Examines product failures and puts corrective and preventative actions in place |
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Resolves analytical issues |
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Revises operating procedures |
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Plans cleaning operations and plant changeovers |
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Covers Safety |
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Reviews training requirements |
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and of course… |
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We cover all aspects of process improvement such as the chemistry, the safety of our staff, the potential impact on the environment, regulatory compliance, the equipment, the handling and isolation, the analysis, cost reduction, raw materials and effluent reduction. |
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The question we keep asking ourselves, Is this the best we can do ? Answer is NO we can still improve . |
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