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Major concerns are:
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Rigorous regulatory review of drugs
Adoption and approval of formulation or process changes that could result in improved life cycles, cost-effective manufacture and waste reduction is often slow. The FDA's introduction of the Process Analytical Technologies (PAT) initiative is set to reverse this trend, encouraging manufacturers to make more use of on-line techniques.
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Wastage is common place
Batch production requires frequent start up and shutdown procedures, increasing rejects and waste. This is an issue as some APIs can be worth as much as $1million / kg. Malvern Insitec can reduce start-up times dramatically.
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Lack of true process understanding
Batch rejects that result from process problems can be higher than 20%, the root cause being a lack of true process understanding. Although in some cases process optimization aspects can be seen as secondary, process understanding offers the opportunity to achieve "quality by design". |
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Lack of ownership for process monitoring
Awareness of the capabilities and limitations of process technology has not always been high at the product development stages for new pharmaceuticals. As a result, when scaling up to full production, process engineers have been unwilling or unable to add technology that might be perceived as requiring additional effort in process validation, and inefficiencies can become institutionalized. Malvern Insitec has a process interface that can be used to measure kilogram's per hour (lab scale) to tonnes per hour (full scale production).
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Highly toxic APIs
Many drugs are toxic at high concentrations - a few grams of API might contain a month's dosage! Operator health and safety concerns are therefore paramount. Exposure must be eliminated during manufacture & QA testing, and generally operators must "suit-up" to take measurement samples, restricting measurements to one sample per batch. Total containment is now possible, and Malvern Insitec forms part of that solution.
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Contamination concerns
No drug manufacturer could allow the possibility of contamination. Manufacture must take place in a FDA Good Manufacturing Practises (GMP) environment, involving intensive cleaning and sterilization, as well as heavy regulatory requirements including Validation, 21 CFR part 11 and electronic data security. An explosive atmosphere (Zone 0) classification is typical where there are solvent vapours. Malvern has worked hard to meet all the pharmaceutical industry requirements.
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