Glossary

Persistent Identifier

Polyisobutylene

Powder In Bottle

Pharmaceutical Inspection Convention (Europe)

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme

An acid or other chemical solution used as a bath to remove scale and oxides from the surface of metals before plating or finishing.

The process of chemically removing oxides and scale from the surface of a metal by the action of water solutions of inorganic acids.

A chemical process for cleaning and descaling stainless steel and other alloy parts, equipment and systems.

The quantity of radioactive material producing 2.22 nuclear transformations per minute.

Proportional Integral Derivative

Pharmaceuticals in the Environment

Personal Identifiable Information

Cold pilgering is a compressive method for simultaneously reducing the Outside Diameter (OD), Inside Diameter (ID), and the wall thickness of a stainless steel tube. Can achieve reductions as high as 90%, with 65% being the normal reduction.

A bioprocessing facility used as an intermediate step in scaling up processes from applied research to full commercial production.

(ICH Q5B) The production of a recombinant protein by a procedure fully representative of and simulating that to be applied on a full commercial manufacturing scale. The methods of cell expansion, harvest, and product purification should be identical except for the scale of production.

(ICH Q5C) The production of the drug substance or drug product by a procedure fully representative of and simulating that to be applied at manufacturing scale. The methods of cell expansion, harvest, and product purification should be identical except for the scale of production.

(ICH Q1A (R2)) A batch of a drug substance or drug product manufactured by a procedure fully representative of and simulating that to be applied to a full production scale batch. For solid oral dosage forms, a pilot scale is generally, at a minimum, one-tenth that of a full production scale or 100,000 tablets or capsules, whichever is the larger.

Personal identification Number

A pressure-tight cylinder used to convey a fluid or to transmit a fluid pressure ordinarily designated “pipe” in applicable material specifications. Materials designated “tube” or “tubing” in the specifications are treated as pipe when intended for pressure service. Types of pipe according to the method of manufacture are:1.Electric resistance-welded pipe (ERW)2.Furnace butt welded pipe, continuous welded3.Electric-fusion welded pipe4.Double submerged-arc welded pipe5.Seamless pipe6.Spiral welded pipe

Pipe size is determined by diameter and either schedule, series or SDR. For bioprocessing equipment, pipe does not include tube.

A slender graduated tube into which small amounts of liquids are taken up by suction, for measuring and transferring.

A cylindrical device used for the conveyance of fluid that is sized by nominal outer diameter dimension.

Primary source of design information for utility systems and process equipment. They are used to depict the process flow, equipment configuration, process parameters, instrumentation, and materials of construction. They also are used to perform overall material and energy balances and pressure balances.

Polyisocyanurate Rigid (foam)