Validating equipment


13-Dec-2019 13:28

(For example, the adhesive used in swabs has been found to interfere with the analysis of samples.)9.2.2 The location from which the sample is taken should take into consideration the composition of the equipment (e.g. Rinse samples may give sufficient evidence of adequate cleaning where accessibility of equipment parts can preclude direct surface sampling, and may be useful for checking for residues of cleaning agents, e.g. Note: This method relies on the manufacture of a placebo batch which is then checked for carry-over of the previous product. It is difficult to provide assurance that the contaminants will be dislodged from the equipment surface uniformly.

Additionally, if the particles of the contaminant or residue are large enough, they may not be uniformly dispersed in the placebo batch.9.4.2 Samples should be taken throughout the process of manufacture.

In establishing residual limits it may not be adequate to focus only on the principal reactant, because other chemical variations may be more difficult to remove.11.11 Certain allergenic ingredients (e.g.

penicillins and cephalosporins) and highly potent material (e.g.

test systems that have met the requirements of the Test System Activation Process and are named within the approved Test Case Reference List (TCRL), as is required for their use by Bluetooth SIG members in qualification.high pressure liquid chromotography (HPLC), gas chromotography (GC), and high pressure thin-layer chromatography (HPTLC)).Other methods may include (alone or in combination) measurement of total organic carbon (TOC), p H, or conductivity; ultraviolet (UV) spectroscopy; and enzyme-linked immunosorbent assay (ELISA).11.1 The acceptance criteria established for contaminant levels in the sample should be practical, achievable and verifi able.Consideration should be given to “non-contact” parts of the equipment into which product or any process material may migrate.

Critical areas should be identified (independently from method of cleaning), particularly in large systems employing semi-automatic or fully automatic clean-in-place systems.6.2 Dedicated equipment should be used for products which are difficult to clean, equipment which is difficult to clean, or for products with a high safety risk where it is not possible to achieve the required cleaning acceptance limits using a validated cleaning procedure.6.3 Ideally, there should be one process for cleaning a piece of equipment or system.

anovulent steroids, potent steroids and cytotoxics) should be undetectable by the best available analytical methods.



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