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USP797 USP800 Cleanroom

Table of Contents

USP797 USP800 Cleanroom

Introduction USP797 USP800 Cleanroom

AXENIC SYSTEMS (established in 1995) is one of the leading companies engaged in planning and installing of USP797 USP800 Cleanroom to carry out different procedures in pharmacies. Proper environmental situations, as outlined by USP 797 and USP 800, help to ensure the efficiency and quality of medications. Accomplishing new standards set forth by USP 797 and USP 800 requires retrofitting an existing structure, which is where consulting our team of highly skilled engineers and professionals is perfect.


USP 797 delivers standards for compounding of sterile arrangements while USP 800 provides standards for the harmless handling of HDs to reduce exposure risks. USP 797 encourages the protection of the sterility of the drug, while USP 800 is concentrated on the safety of personnel who come in contact with the Hazardous Drugs.


Within USP 797 classification compounding pharmacies are essential to compound sterile preparations (CSPs) using a laminar flow workstation inside a clean room. Sterile compounding is classified into 3 risk groups: Low Risk, Medium Risk, and High Risk. If the institution prepares CSPs, which meet the definition of the precise categories, defined in USP Chapter 797 you must comply with USP 797. The standards are applied to all peoples who organize CSPs and all places where CSPs are prepared including physicians’ workplaces.


USP 800 enlarges controls for the protection of workforces and environments against hazardous drug compounds. In contrast to USP 797, which only remedies sterile compounding events, USP 800 takes a 360-degree methodology for processing hazardous drugs. USP 800 defines new controls over compounding surroundings and equipment that apply to both hazardous and non-hazardous, sterile and non-sterile compounding. The USP 800 compliance limit accompanies a USP suggestion for early organizational acceptance. Diligent protection of healthcare physicians and others when handling hazardous drugs is a top priority.


  • The USP 797 outline contains proper laminar flow, operation techniques, air and room cleanliness, and workstation placements. 
  • They can be easily extended or modified.
  • The USP 800 dictates further requirements for cleanrooms dealing with harmful drugs or materials that need extra levels of safety and hygiene. 
  • Even though the mechanisms of USP797 USP800 Cleanroom are somewhat complicated, it can still be customized with a wide range of special features and equipment to make sure that it meets the application’s particular needs.
  • USP797 USP800 Cleanroom allows the modification of the lab easily as it provides enhanced flexibility. 


For a full USP compounding suite containing both 797 and 800 containments, some may think this requires individually constructed partitions, multiple gowning rooms, air showers, and individual entry and exit. The USP 797 and 800 cleanrooms deliver cross-functional structures with parallel rooms that share entrances and gowning spaces. 

Equivalent designs deliver the proper ante-room requirements via cascading air systems. For example, the ISO 8 ante-room meets the necessities for a USP 795 area, which also provides access to the more critical gowning for the USP 797 and 800 rooms. Incorporated designs decrease the overall footprint, structural demands, and air requirements for each suite.

Some major points considered for cleanroom construction:

Risk and Schedule Management: –
Our leading project control team takes a pre-emptive approach throughout the project life cycle in considering schedules and risks – key factors in the success of any project. As the construction manager and prime, we assess all of our trade partner sub-contractors against our safety, capability, and financial strength standards.

Sub-contractor Supervision: –
We have solid relationships with local subcontractor communities throughout the globe. We build a proposal list of local trade contractors who are familiar with the location, region, and project type from our proprietary contractor database.

Resources Management: –
Our procurement experts enhance supply chain procedures to ensure the most cost-effective development, obtaining, purchasing, moving, storing and controlling of materials. We have enthusiastic expertise in logistics as well as expertise in obtaining owner equipment, trade and professional services and materials in addition to subcontracts for construction.


  • The purpose of USP 797 cleanroom is to deliver standards that set the minimum threshold essential for your operations to be considered safe for the preparations of compounded sterile products. Further, these standards also ensure that the compounded sterile products are of high-quality.
  • The USP 800 cleanroom is used to protect workforces handling hazardous drugs (both non-sterile and sterile) and the surroundings around which they are being handled.

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