Media fill studies

Aseptic Filling Validation (Media Fill Studies)... 

All documents of batch numbers 001, 002, and 003 (process simulation of 24-hour duration) of media-fill study 1, study 2, and study 3 for aseptically filled A-ml vials were reviewed and found to meet the media-fill qualification requirements per current USP monograph and ISO 13408-1 1998 (E), including process simulation, environmental and personnel monitoring results. 

Media fill studies do not adequately support sterile product expectations in that... 

ASEPTIC FILLING VALIDATION (MEDIA FILL STUDIES)... 

Worst-case, challenges such as personnel breaks, equipment adjustments, and additional personnel in the fill room will be incorporated into all media fill studies. Stoppers and vials or ampoules will be sterilized. The time between sterilization and the start of the first media fill will be the maximum validated storage time for sterile stoppers, vials, and ampoules, provided the media fills meet all other acceptance criteria. 

Aseptic filling validation (media fill studies) Cross-contamination control Computerized pharmaceutical system Quality assurance/control laboratory validation... 

The whole operation of forming a sterile container, filling it, and sealing it, is conducted within one machine. The filling zone for aseptic filling is afforded localized filtered air protection. There is no intervention from personnel until after the filled presentation is sealed and automatically moved away from the point of fill. What need therefore for location within a Class 100 clean room, or for protection by the double barrier principle Support for this argument has come mainly from media fill studies conducted with machines located in Class 10,000 areas [10]. Accumulation of uncontaminated individual trials, each of several units of thousands of items to total numbers of several tens and even hundreds of thousands of items has been used to claim equivalence between form-fill-seal in Class 10,000 clean rooms with conventional double-barrier aseptic fill in Class 100 clean rooms. 

The same type of problems occur when making i.r. measurements with DACs. It is now preferable to use Fourier-transform (FT) interferometers, which are commercially available. In this case, the incident i.r. beam, which is a few millimetres in diameter, must be focused to less than 100 (jim by suitable mirror optics (see Fig. 3.32). This procedure can be avoided for studies of homogeneous samples, filling the DAC experimental volume, especially when the intense beam from synchrotron radiation is used, although the useful throughput is a very small fraction (10 - 10 ) of the available light. However, it cannot be avoided when solid samples embedded in a transparent pressure medium are studied. 

A similar catalytic dimerization system has been investigated [40] in a continuous flow loop reactor in order to study the stability of the ionic liquid solution. The catalyst used is the organometallic nickel(II) complex (Hcod)Ni(hfacac) (Hcod = cyclooct-4-ene-l-yl and hfacac = l,l,l,5,5,5-hexafluoro-2,4-pentanedionato-0,0 ), and the ionic liquid is an acidic chloroaluminate based on the acidic mixture of 1-butyl-4-methylpyridinium chloride and aluminium chloride. No alkylaluminium is added, but an organic Lewis base is added to buffer the acidity of the medium. The ionic catalyst solution is introduced into the reactor loop at the beginning of the reaction and the loop is filled with the reactants (total volume 160 mL). The feed enters continuously into the loop and the products are continuously separated in a settler. The overall activity is 18,000 (TON). The selectivity to dimers is in the 98 % range and the selectivity to linear octenes is 52 %. 

Wu [353] who studied extruded fiber-filled composite samples established that the distribution of fibers along the radius of the specimen depended on the extrusion rate at low rates the fiber distribution is uniform, at medium rates the minimum of filler concentration occurs at 0.63 R (R is the extrudate radius) (in case of spherical particles this point corresponds to the maximum filler concentration) at high extrusion rates most of the fibers are concentrated about the flow axis and there are almost none on the extruded sample surfaces. 

The transport of many compounds takes place through interstices of polymer chains filled with aqueous medium [52], In such cases, the rate of mass transport is directly proportional to the degree of hydration of the membranes [53]. The most widely accepted method for determining the hydration of membranes is to equilibrate the membranes in water or buffer and weigh these membranes after blotting [54], In a newer method, the matrices to be studied are placed on a sintered glass funnel which is attached to a capillary filled with water. The absorption of water results in the movement of the capillary front [55],... 

In a study that addressed the effect of doping on quantum dots, the donor and acceptor levels were found to be practically independent of particle size [De3]. In other words, shallow impurities become deep ones if the dot size is reduced. Experimental observations show that the luminescence is not affected by doping if a thermal diffusion process, for example using a POCl3 source, is used [Ell]. Implantation, in contrast, is observed to effectively quench the PL [Tal4]. If the pores are filled with a medium of a large low-frequency dielectric constant, such as water or any other polar solvent, it is found that deep impurity states still exist,... 

The question arises whether the studied thyxtropic phenomena should be taken into account in mould filling with plastisols of Type II, i.e. to assume medium instantly reacting to loading like plastisols I. This is supported by experimental data used in Fig. 4. As is seen, the stress responds instantly both on its fall and rise. Hence,... 

The phenomenon of electro-osmosis can be studied by using a U-tube [fig. (9)] in which a plug of moist clay (a negative sol) is fixed. The two limbs of the tube are filled with water to the same level. The platinum electrodes are dipped in water and potential applied. It is observed that water level rises on the cathode side, while it falls on the anode side. This motion of the medium towards the negative electrode, shows that the charge on the medium is positive. Similarly, for a positively charged sol, electro-osmosis will occur in the reverse direction. 

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