Flexible Hose There Is No Reference For Practicality
Flexible Hose are ubiquitous in the production of pharmaceutical products.
Now how do I handle Flexible Hose? What is the current level of technology? Is there a reference for usability?
The general requirements for pipes and Flexible Hose are similar: Flexible Hose, together with the entire production equipment, should be suitable and easy to clean. In addition, they should not adversely affect the quality of the drug.
However, compared with the fixed installation of the pipe, the hose has some shortcomings, look to know. The first is the standard, and stainless steel, and the product and clean media in contact with the hose should have a certificate. It is necessary to demonstrate that the hose material does not affect the product. In Europe, the current regulations on stainless steel material certification are clear: the gold standard is DIN EN10204-3.1 certificate. While the hose has a number of potential and generic proof. For example, according to FDA 21 CFR 177.2600, the German Federal Institute allows import lists or EC1935 / 2004 (materials and articles in contact with foodstuffs), EC2023 / 2006 (Good Manufacturing Practices for Food and Food Contact), Pharmaceutical Water The hose used requires a bill of material. Indeed, this is absolutely perfect for many purified water Flexible Hose. Proof of BSE / TSE (BSE: BSE: Infectious Spongiform Encephalopathy) according to USP identified as Grade VI or Expect "No ADI" (raw material does not contain animal derived ingredients) and source, production and processing Most of the use of pharmaceutical water is a bit too much.
Depending on the area used, the cyclic pressure test is required.
And that's just the beginning.
The hose needs to be confirmed before use. During the validation process, some factors need to be checked or determined, such as cleaning, disinfection, intended use (for single use / multiple uses), such as extract, inner surface, particle release, durability check, test procedure. In the confirmation process, the following hold times also need to be determined:
The maximum time to be cleaned / disinfected / sterilized after use
Allow the maximum length of the hose to be used (before processing again)
The hose is stored until the maximum time is required for further processing or replacement
The hose used in the clean area (including the Class C cleanroom) should be smooth inside and outside the surface for easy cleaning. So the cloth hose is not allowed to use. Taking into account the clean, clean steam dedicated stainless steel braided hose is also very dangerous.
For pipes, it should be identified. Not only refers to the media, each individual pipe should be clearly identified. In this way, the state of the hose (use, processing status, use time, use period, as above) can be clearly identified before use. In addition to the logo, the hose needs to be properly stored and locked correctly.