USP797 USP800 Cleanroom

We are recognised manufacturer, supplier and exporter since past several years in Clean room business. We understand client's requirement and application as per that give solutions so his need can be fulfilled. While designing and manufacturing of USP797 USP800 Clean room, our Experienced and professional employees knowledge comes into play to make sure to serve client with best solution...

It's our pleasure to help your pharmacy meet the requirements.

• Wipe down Pharmacy cleanrooms
  • New modular construction
  • Upgrade existing room to cleanroom
  • Gowning room / airlock
• Custom Class 100 cleanroom benches
• Cleanroom cabinets and tables
• Pass Thru's
• Cleanroom certification

Within USP 797 classification combination pharmacies are needed to compound sterile preparations (CSPs) utilizing a streamline flow digital computer among a Clean room. Sterile combination is assessed into three risk groups: Low Risk, Medium Risk, and High Risk. If your establishment prepares CSPs that meet the definition of the precise classes, delineated in USP Chapter 797 you want to suits USP 797. The standards are applied to all persons who prepare CSPs and all places where CSPs are prepared including physicians' offices.

The USP 797 cleanroom requirement are usual in nature; however check with the International Standards Organization ISO-14644 standards for cleanrooms. to realize USP 797 compliance, pharmacies should perform sterile drug combination among associate degree ISO 5 (Class 100) hood atmosphere, fenced in among a bigger combination "Buffer Zone" of ISO 7 (Class 10000) positive pressure controlled-air atmosphere (Cleanroom). The ISO 5 combination atmospheres are often maintained utilizing a streamline flow Work Station among associate degree ISO 7 cleanroom. Maintaining the correct pressure among the cleanroom should be evaluated and brought into thought once planning and equalization the general sterile atmosphere. To be in compliance with USP-797 the cleanroom style additionally must meet the standards for the danger level of protection for sterile combination. Our Cleanroom Systems offers a range of controlled atmosphere solutions to satisfy the USP 797 combination laws.

Can ready-made, non-shedding, standard area clean room} walls meet the USP 797 laws and might be designed as a very detached self-contained room or in affiliation with existing walls. Standard wall panels made from FRP (reinforced plastic) and HPL (high pressure laminate) are used most frequently in pharmaceutical, USP 797 combination rooms, and medical device clean rooms. These panels will stand up to continual cleanup and sanitizing while not breaking down..

USP800 rules propose changes handling hazardous drugs (HD) that affect cleanrooms:

• Require negative pressure rooms and BSC
• Signs and de-marketing lines warning of hazard
• Labeling requirements
• Storage requirements
• Pass thru requirements