Contaminant Identification in Pharmaceuticals and Chemicals Processing

Intertek ASG Laboratory, Manchester, UK

Contaminant Identification:

Pharmaceuticals and Chemicals Processing

Intertek ASG is able to help customers solve problems of contamination in products and in-process intermediates, either as unidentified particulates, fibres or other extraneous materials, and also undesired chemical components outside the normal process operating window. Experience includes degradation products and side products, cleaning residues and materials introduced by mechanical degradation of process equipment. The regulatory and “on-plant” support experience of Intertek ASG ensures that this service is particularly well suited to Fine Chemical and Pharmaceutical manufacturing sites working in demanding regulatory environments such as GLP and GMP.

Specific expertise Intertek ASG can bring to bear on contaminant problem solving includes:

Broad expertise in chemical and physical characterisation of a huge range of organic and inorganic substances
Specific expertise in the detection and quantification of organic volatile impurities (OVI), residual solvents and in surfactant analysis
Excellent capability in a range of microscopies, also coupled with ability to carry out elemental and structural analysis
Informatics tools including data management, visualization and analysis and experimental design
Broad awareness of the challenges faced by manufacturing engineers and process chemists
Tailored project management approach to problem solving used proven protocols
Track record (see case studies) in working with leading chemicals companies on diverse contamination problems

In addition Intertek ASG is able to draw on wider expertise within the international Intertek Outsourced Laboratory network.

In response to a specific enquiry, Intertek ASG will work closely with the customer to go through a standard problem definition phase and then seek to identify the best multi-skilled approach to problem solving. Where appropriate, ASG scientists will go out to visit customer's plants and work jointly with on-site teams to solve the problem.