T&E - Analítica






CLEANING VALIDATION

 

ABOUT CLEANING VALIDATION

 

One of the concerns with the manufacture or formulation of the products is the contamination that will remain from the contaminated product to another product, if the cleaning of the equipment that served the product in its development or to the mixtures is not evidenced.

 

Usually the pharmaceutical or pharmacochemical industries work with equipment called poly purposes, that is, they serve for more than one product. Thus, when exchanging products, it should be ensured that there is no previous asset residue not only in the reactor, but also in its pipes or fittings in predetermined minimum concentrations possible to contaminate the new product.

Several are the cleaning processes and are linked to the solubility of the product worked there. After the last wash (rinsing), the residue can be analyzed in the rinsing liquid.

Another technique is the use of the plate swab of the metal or the material of the reaction system, as can be seen below.

 

 

 

For the Swab, usually a metal plate of the equipment (both, mixer, filter, etc.) in pre-established dimensions for the expression of the result. Under this plate the product of interest is added with clear technique. It contacts or dries by temperature or by insufflation of gas. The perimeter is defined in the size of the plate, as well as the insertion of the pattern of the substance of interest on the plate. Which is later analyzed in content and expressed on the size of the plate which will be reproduced for the area of the equipment.

Different cleaning validation leads may be challenged depending on the process used for the manufacture of the IFA or the formulation. The Limits of Quantification are in low concentration which requires complex and high resolution equipment.

 

The T&E Analytical Center conducts the complete cleaning validation test including, limit calculation, LD / LQ, recovery and validation, regardless of the cleaning methodology to be employed.

 

ANALYTICAL TECHNIQUES

 

Identification and Quantification

The most used analytical techniques for Clean Validation are in function of the molecule and the analytical resources employed, among the techniques most used are:

 

·         Gas-phase Chromatography (GC-FID-ECD-TCD-MS-Head Space);

·         Liquid phase chromatography (UPLC or HPLC-UV / Vis; Fluorescence; ELSD);

·         LC-MS / MS: Mass Spectrometry coupled to HPLC or UPLC; 

·         ICP-OES (Induced-Simultaneous and Sequential Plasma);

·         AA - (Atomic Absorption) and FC (photometry of flame).

·         Determination of peak purity using DAD.

 

Other solutions may occur during the technical exchange and thus, solve the problem of your company.