Glossary

TCP/IP protocol that is used to log onto the network, list directories, and copy files. It can also translate between ASCII and EBCDIC.

Communications protocol that can transmit binary and ASCII data files without loss of data.

Preparation of parenteral drugs, either LVPs or SVPs, demands the highest level of contamination control, because the human body’s normal defenses against infection are bypassed when parenteral medications are introduced either intramuscularly (I.M.) or intravenously (I.V.) directly into the body. The processing of raw materials into finished dosage forms must comply at all times with cGMPs and must be able to support process validation. Mechanical design should include HVAC Classifications considered essential to attain global regulatory acceptance. For classifications see the ISPE® Guide for Sterile Manufacturing Facilities.The desire for increased levels of sterility assurance has led the FDA to promote the use of terminal sterilization for aseptically filled products. The FDA has stated that terminal sterilization processing is the method of choice unless the manufacturer can show that it is detrimental to the product. Terminal sterilization may be accomplished using autoclaves that apply overpressure to balance the pressures that are developed across the inside and outside of the containers. Because of product sensitivities, biologics and blood products are not appropriate applications for terminal sterilization.

A third material that is melted concurrently with the parent metal during fusion or braze welding. It is usually, but not necessarily, of different composition from the parent metals.

A fusion weld, other than a butt, edge or fusion spot weld, which is approximately triangular in transverse cross-section.

Porous material through which a liquid or gas medium is passed so that particulates and impurities are held in suspension and removed from the feed stream.

Cells are grown on an open mesh of an inert material, which allows the culture medium to flow past it but retains the cells. This is similar in idea to membrane and hollow fibre reactors, but can be much easier to set up, being similar to conventional tower bioreactors, but with the meshwork replacing the central reactor space.

A graphical representation of individual filter performance, based on continuous turbidity measurements or total particle counts versus time for an entire filter run, from startup to backwash inclusively, that includes an assessment of filter performance while another filter is being backwashed.

System composed of filter, frame and other support system or other housing.

The part of a mixture that passes through a filter, also called permeate.

A purification process in which the passage of fluid through a porous material results in the removal of impurities based on the physical interaction of the impurities with that porous material.

Removal of suspended matter from a fluid by passing it through a porous matrix that prevents particles from getting through, usually by entrapment on or in the filter matrix.

The final drug product after chemical or biological processing and purification, ready for concentration, drying, and filling into containers prior to dispensing and final filling.

Material that has undergone all the steps of production except for the final filling. It consists of one or monovalent pooled harvests, from cultures of one or more species or types of microorganism, after clarification, dilution or addition of ant adjuvant or other auxiliary substance. It is treated to ensure its homogeneity and is used for filling the containers of one or more final lots (batches).

Filters in a final position before the air enters the cleanroom.

A collection of closed, final containers or other final dosage units that are expected to be homogeneous and equivalent with respect to risk of contamination during filling or preparation of the final product. The dosage units are filled, or otherwise prepared, from the same bulk vaccine, freeze-dried together (if applicable) and closed in one continuous working session. They bear a distinctive number or code identifying the final lot (batch). Where a final bulk vaccine is filled and/or freeze-dried on several separate sessions, there results a related set of final lots (batches) that are usually identified by the use of a common part in the distinctive number or code; these related final lots (batches) are sometimes referred to as sub-batches, sub-lots or filling lots.

(also see: Particulates)

In genetics, the identification of multiple specific alleles on a person’s DNA to produce a unique identifier for that person.

A medicinal product that has undergone all stages of production, including packaging in its final container.

Sequence in which bases are identified to an accuracy of no more than 1 error in 10,000 and are placed in the right order and orientation along a chromosome with almost no gaps.

Finite Element Analysis (FEA) is a computer-based numerical technique for calculating the strength and behavior of engineering structures. It can be used to calculate deflection, stress, vibration, buckling behavior and many other phenomena.

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