Isolator Technology With the Patient in Mind

The appropriate barrier system should be selected using a logical, risk-based approach, with awareness of all the possible sources of contamination. Nothing can come of nothing, but the contamination of a drug can come from everything. Selecting the appropriate barrier system for protecting the product and/or the environment requires a logical approach while recognizing the various routes of possible contamination in the aseptic processing chain.he ultimate goal of pharmaceutical manufacturing is to satisfy the patient.We do this fairly well because we are all po ten tial pati en t s .

Am ong the va rious probl ems rega rding ph a rm aceutical devel opm ent are those rel a ted to the produ cti on of sterile or toxic produ ct s . Sterile products such as inject a bl e s — except those compatible with terminal steri lization—must proceed through the uncert a i n ty of the asepti c process under the stri ct regulations and constraints issued by the US Food and Drug Ad m i n i s tration and the Eu ropean Com m i ss ion’s European Agency for Evaluation ofMedicinal Produ cts (1, 2), wh i ch aim to isolate produ cti on as mu ch as po s s i ble from its surroundings (see Figure 1).

Toxic produ cts are def i n ed by the risk they pose du ring their processing, either by their operator exposure level if the molecule has been subjected to toxicological trials for its classificati on or by the cauti on a ry “one molecule” t h eory, which notes that risk exists even from one molecule of a particular produ ct. In ei t h er case, this risk leads to performing the process with a defined segrega ti on between the product and the pers on n el and/or production environment.

View Full article