USP <788> Regulations For Liquid Particle Counters In Cleanrooms

USP <788> Regulations For Liquid Particle Counters In Cleanrooms Medium Image

What happens if an injectable is contaminated? Infections, complications, vein irritation, local tissue infarction, anaphylactic shock, other health risks, and potentially death… The end-user is put in jeopardy. That is why it is vital we prevent contamination at the source: in the cleanroom during the manufacturing of the pharmaceuticals. This involves utilizing a liquid particle counter  to check the liquid for contamination.

The Food and Drug Administration (FDA) is the responsible authority for monitoring the cleanliness of injectables. They define the standards and good manufacturing practices (GMPs). They also have developed the United States Pharmacopoeia, which is a guide defining the production of pharmaceuticals to prevent contamination.

We define particles in injections as extraneous, mobile, undissolved particles that are unintentionally present in the end product. They can come from a myriad of sources, including packaging materials, cleanroom personnel, and different ingredients. But no matter where it comes from, the presence of particles is hazardous to the end-user.

In the manufacturing of these medicines and devices, it is critical we adhere to these guidelines to prevent yield loss, fines, costly process redesigns, and, most importantly, health complications.