{"id":9447,"date":"2022-02-21T19:55:00","date_gmt":"2022-02-21T19:55:00","guid":{"rendered":"https:\/\/www.golighthouse.com\/en\/?post_type=knowledge-center&p=9447"},"modified":"2022-11-15T20:04:40","modified_gmt":"2022-11-15T20:04:40","slug":"usp-788-regulations-for-liquid-particle-counters-in-cleanrooms-572","status":"publish","type":"knowledge-center","link":"https:\/\/www.golighthouse.com\/en\/blog\/usp-788-regulations-for-liquid-particle-counters-in-cleanrooms-572\/","title":{"rendered":"USP <788> Regulations For Liquid Particle Counters In Cleanrooms"},"content":{"rendered":"\t\t
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What happens if an injectable is contaminated? Infections, complications, vein irritation, local tissue infarction, anaphylactic shock, other health risks, and potentially death\u2026 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\u00a0liquid particle counter<\/a>\u00a0 to check the liquid for contamination.<\/p>

The\u00a0Food and Drug Administration (FDA)<\/a>\u00a0is 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.<\/p>

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.<\/p>

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.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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What Is USP <788>?<\/strong><\/h2>

The United States Pharmacopoeia 788\u00a0(USP <788>)<\/a>\u00a0defines the standards for testing water for injectables (WFI) developed in cleanrooms. This standard defines two ways to test for particles: light obscuration and microscopic assay. Typically, water is first tested using light obscuration. If the liquid fails the parameters using light obscuration, a microscopic assay is used as a secondary testing measure.<\/p>

There are two ways to package this WFI: large volume parenteral (LVP) and small-volume parenteral (SVP). LVP means that the injectable is packaged in a single-dose vial containing 100ml or more of the solution, whereas SVP contains less than 100ml. Both light obscuration and microscopic assay are accepted testing methods for determining if there are sub-visible particles present.<\/p>

USP <788> Validation Requirements<\/h2>

USP <788> requires validation of your liquid particle counter every six months. The liquid particle counter is what is used to conduct the particle checks, although we’ll talk more on exactly how that works in just a moment.<\/p>

To validate liquid particle counters, we commonly use Count-Cal particles manufactured by\u00a0Thermo Scientific<\/a>. They are designed to fit into the\u00a0National Institute of Standards and Technology’s (NIST)<\/a>\u00a0traceable diameters. Their accuracy is 3000\/ml \u00b110%. This allows you to calibrate your equipment within USP <788> standards. Because the validation testing requires several tests, you are able to document that your liquid particle counter is able to replicate the correct readings. This is an important part of documenting your traceable GMPs.<\/p>

Your liquid particle counter must be calibrated at your location – and then not move from that spot – according to USP <788>. The basic requirements for validation include:<\/p>