Procedure packs

The manufacturer of a Class I device or of a custom-made device, or a person who markets a system or procedure pack, must inform the competent authority of the manufacturer s registered place of business and the description of the devices concerned.Such manufacturers who are located outside the EEA must designate persons established within the Community who are responsible for such registration. 

They have packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the original manufacturers. 

The system or procedure pack must not bear additional CE marking and must be accompanied by the original manufacturers information. The declaration must be kept for 5 years. 

Where the above conditions are not met, as in cases where the system or procedure pack incorporates devices that do not bear CE marking or where the chosen combination of devices is not compatible in view of their original intended use, the system or procedure pack must be treated as a device in its own right and the appropriate conformity assessment procedure must be followed. 

A non-EEA manufacturer may place a Class I or custom-made medical device or a system or procedure pack on the EU market under their... 

Procedure Packed erythrocytes, washed twice in Hepes buffer, are resuspended in an equal volume of the same buffer. The erythrocyte suspension (2 ml) is carefully layered over the Percoll-diatrizoate solution (2 ml) in a glass centrifuge tube with an internal diameter of 10 mm. After centrifugation at 400 x g for 20 min at room temperature, erythrocytes with normal density are carefully removed from the surface of the Percoll-diatrizoate cushion using a pasteur pipette. This fraction is referred to as the normal density fraction. Erythrocytes with elevated density, which had pelleted below the Percoll-diatrizoate, can then be removed in a similar manner. This latter fraction is referred to as the dense fraction. Finally, each fraction of erythrocytes is washed twice in 10 vol. of Hepes buffer at 4°C. 

All BioProcess Media have chemical stability to allow efficient cleaning and sanitisation procedures. Packing methods are established for a wide range of scales and compatible large scale columns and equipment are available. 

In Table 5.3, is compared with the total hydroxyl concentration (Ni, + N ) of the corresponding fully hydroxylated, sample. The results clearly demonstrate that the physical adsorption is determined by the total hydroxyl content of the surface, showing the adsorption to be localized. It is useful to note that the BET monolayer capacity n JH2O) (= N ) of the water calculated from the water isotherm by the BET procedure corresponds to approximately 1 molecule of water per hydroxyl group, and so provides a convenient means of estimating the hydroxyl concentration on the surface. Since the adsorption is localized, n.(H20) does not, of course, denote a close-packed layer of water molecules. Indeed, the area occupied per molecule of water is determined by the structure of the silica, and is uJH2O) 20A ... 

Discussion of the concepts and procedures involved in designing packed gas absorption systems shall first be confined to simple gas absorption processes without compHcations isothermal absorption of a solute from a mixture containing an inert gas into a nonvolatile solvent without chemical reaction. Gas and Hquid are assumed to move through the packing in a plug-flow fashion. Deviations such as nonisotherma1 operation, multicomponent mass transfer effects, and departure from plug flow are treated in later sections. 

Design Procedure. The packed height of the tower required to reduce the concentration of the solute in the gas stream from to acceptable residual level ofjy 2 may be calculated by combining point values of the mass transfer rate and a differential material balance for the absorbed component. Referring to a sHce dh of the absorber (Fig. 5),... 

Under constant pattern conditions the LUB is independent of column length although, of course, it depends on other process variables. The procedure is therefore to determine the LUB in a small laboratory or pilot-scale column packed with the same adsorbent and operated under the same flow conditions. The length of column needed can then be found simply by adding the LUB to the length calculated from equiUbrium considerations, assuming a shock concentration front. 

One report (13) describes the procedure for spinning dry asymmetric ceUulose acetate fiber with a bore skin. Such fibers are spun in a modified dry-spinning process in which a volatile Uquid (methyl formate) is used as the ceUulose acetate solvent. The bore coagulating Uquid is isopropyl alcohol, which is subsequentiy removed. The advantages of these dry fibers over most ceUulose acetate membranes are that they can be stored dry, they are wet-dry reversible, they can be sterilized and packed dry, and they are ready for use without removal of preservatives. 

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