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USP 800 BioSafe® Hazardous Drug Compounding Clean Room


Custom BioSafe® Stainless Steel Hazardous Drug Compounding Cleanroom
See all of Terra's
products used for
USP 797/800 Compounding

Cleanroom Client List
Dozens of customers for
Terra modular cleanrooms

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See Below
 
  • Complete turnkey clean room meets cleanliness standards for control of submicron particles, ensuring a clean compounding environment
  • Exhaust containment system pulls air from compounding room to create negative-pressure containment of hazardous drugs, in accordance with USP 800
  • Available with USP 797 positive-pressure room for non-hazardous compounding
  • Select ISO cleanliness level to suit your application: ISO 7 rooms for sterile-to-sterile compounding, or ISO 5 rooms for non-sterile-to-sterile compounding
  • Environmental Control System provides monitoring, control and data logging of critical room pressure levels from a central touchscreen console, simplifying operation and certification
  • Internal walls with swing doors create a separate gowning ante-room
  • Snap-in-place wall panels create a rigid, durable structure that requires no external bracing or ceiling support
  • Double-wall, insulated 304 stainless steel panels with radius corners provide clean, ISO 5-compatible interior surfaces that are easy to clean and sterilize
  • Includes differential pressure gauges to simplify cleanroom certification

All standard room designs feature an 8-ft. ceiling height (filter face to floor). Exterior height: 109"

Terra Universal's Environmental Control System
All USP 800 models include a Tier II Environmental Control System, which allows pharmacists to configure their compounding cleanroom to optimal operating conditions.  These systems provide automatic monitoring, fine adjustments, and traceable documentation to simplify certification and meet environmental monitoring requirements for regulatory audits (such as FDA inspections).
  • 3.5” touchscreen console display for easy set-up and monitoring of conditions in each room
  • Ethernet connection for logging and storage of room pressures or other data
  • Pressure sensors in each room
  • Individual variable control over all Fan/Filter Units to achieve target flow and pressure levels
  • Fan performance and room pressure warning alerts via Ethernet
  • Remote setback and shutdown capability
  • Clock-calendar control of energy-saving setback mode
aircare_acc7015_console

Declaration of UL Listing
Includes declaration of system listing under UL File E472687, including all high-voltage Modular Cleanroom electrical components integrated into Power Distribution System (Terra Nos. 6600-29B-P, 6600-29B-S, 6600-29B-B, 6600-29B-P-220, 6600-29B-S-220, 6600-29B-S-220, 6600-27, 6600-27-220). UL listing helps meet municipal and other permitting requirements that may apply.
Cat. # Price
6600-33 call TUI

Optional Configurations:
  • Local (SD card) data logging
  • Dynamic fan/filter control to automatically maintain target pressure or airflow performance
  • Room sensors for temperature, relative humidity, particle counts or occupancy sensing
usp 800 room usp 800 room
ISO 5 Containment Room with Class II,
B2 Biological Safety Cabinet
ISO 7 Containment Room with Class II,
B2 Biological Safety Cabinet
usp 800 room usp 800 room
Exiting Ante-Room Control Panel, showing optional Digihelic® Differential Pressure Gauges (in place of standard Magnehelic® Gauges)

Ordering Information - Call Terra to discuss custom sizes or configurations

Clean Rooms Optimized For Outsourcing Facilities (Section 503B)

The FDA enforces standards for outsourcing facilities referred to as Current Good Manufacturing Practices (CGMPs), which are a strict set of quality assurance requirements intended to prevent potentially deadly contamination of CSPs.  All 503B compounding pharmacies must comply with CGMP standards (21 CFR Parts 210 and 211) and will be inspected by the FDA upon registration.  In addition to satisfying quality assurance requirements, the FDA also expects all pharmaceutical compounders to comply with national industry standards (i.e. USP 797 and 800). Outsourcing facilities must also comply with any applicable state regulations, including licensing requirements.

In order to best ensure compliance with CGMP standards, experts in the field of pharmaceutical compounding strongly recommend using an ISO 5 cleanroom to substantially lower the bioburden of the cleanroom environment and restrict the number of colony-forming units (CFUs) introduced into the critical areas.  A "cleaner" compounding cleanroom will help prevent sterility test failures (e.g. viable air sampling and fingertip sampling) and avoid additional scrutiny from the FDA and State Boards of Pharmacy.

The designs below reflect these recommendations for non-sterile-to-sterile (high-risk) compounding and for outsourced compounding operations.

CGMP HD Compounding Cleanroom
Complies with: FDA cGMP, USP 797, and USP 800

Non-Sterile-to-Sterile Hazardous Drug Compounding to ISO-800 & DQSA Section 503B Requirements
CGMP HD Compounding Cleanroom
ISO 5 Hazardous Drug Compounding Room with ISO 7 Anteroom
Nominal Dimensions: W x D x H feet (mm) Exhaust*
(CFM)
Panel
Type
Cat. # Price
Overall Containment
Room
Ante-Room
12 x 10 x 8
(3658 x 3058 x 2438)
8 x 10 x 8
(2438 x 3058 x 2438)
4 x 10 x 8
(1219 x 3058 x 2438)
4500 304 Stainless Steel 2899-13-SS call TUI
12 x 12 x 8
(3658 x 3658 x 2438)
8 x 12 x 8
(2438 x 3658 x 2438)
4 x 12 x 8
(1219 x 3658 x 2438)
5500 304 Stainless Steel 2899-15-SS call TUI
* Volume of air that must be exhausted from containment room to create adequate negative pressure. Exhaust fan not included; see Exhaust Requirements below.

CGMP Dual Purpose HD/Non-HD Compounding Cleanroom
Complies with: FDA cGMP, USP 797, and USP 800

Non-Sterile-to-Sterile Hazardous Drug Compounding to ISO-800 & DQSA Section 503B Requirements
CGMP Dual Purpose HD/Non-HD Compounding Cleanroom
ISO 5 Hazardous Drug Compounding Room and ISO 6 Non-Hazardous Drug Compounding Room (with ISO 7 Anteroom)
Nominal Dimensions: W x D x H feet (mm) Exhaust*
(CFM)
Panel
Type
Cat. # Price
Overall Containment
Room
Ante-Room Positive-Pressure
Room
18 x 10 x 8
(5486 x 3058 x 2438)
8 x 10 x 8
(2438 x 3058 x 2438)
4 x 10 x 8
(1219 x 3058 x 2438)
6 x 10 x 8
(1829 x 3058 x 2438)
4500 304 Stainless Steel 2899-09-SS call TUI
18 x 12 x 8
(5486 x 3658 x 2438)
8 x 12 x 8
(2438 x 3658 x 2438)
4 x 12 x 8
(1219 x 3658 x 2438)
6 x 12 x 8
(1829 x 3658 x 2438)
5500 304 Stainless Steel 2899-11-SS call TUI
* Volume of air that must be exhausted from containment room to create adequate negative pressure. Exhaust fan not included; see Exhaust Requirements below.

Clean Rooms Optimized For Traditional Compounding Pharmacies (Section 503A)

Traditional compounding pharmacies are not required to comply with CGMP standards.  However, as a result of the 2013 Drug Quality and Security Act (DQSA), all traditional compounding pharmacies are subject to FDA oversight and are inspected on a risk-based schedule. Any “insanitary conditions” are in direct violation of Sections 501(a)(1) and (a)(2)(A) of the FD&C Act (Title 21 CFR), which gives the FDA inspectors broad secretion for determining what constitutes sterile conditions.

Due to stricter enforcement of compounding standards by the FDA, Terra Universal always recommends a CGMP-grade compounding cleanroom to reduce the risk of non-compliance and allow for maximum operational flexibility.

The State Boards of Pharmacy have also stepped up enforcement of USP compounding standards and in some cases have implemented regulations that exceed the minimum USP requirements. Regulations will vary from state to state and a compounding pharmacy must always comply with any state-specific requirements.

The economical designs below reflect minimum USP compliance only and may not suffice for an FDA-level inspection.

HD Compounding Cleanroom
Complies with: USP 797 and USP 800

Sterile-to-Sterile Hazardous Drug Compounding to ISO-800 Requirements
Hazardous Drug (HD) Compounding Cleanroom
ISO 7 Hazardous Drug Compounding Room with ISO 7 Anteroom
Nominal Dimensions: W x D x H feet (mm) Exhaust*
(CFM)
Panel
Type
Cat. # Price
Overall Containment
Room
Ante-Room
12 x 10 x 8
(3658 x 3058 x 2438)
8 x 10 x 8
(2438 x 3058 x 2438)
4 x 10 x 8
(1219 x 3058 x 2438)
1800 304 Stainless Steel 2899-04-SS call TUI
12 x 12 x 8
(3658 x 3658 x 2438)
8 x 12 x 8
(2438 x 3658 x 2438)
4 x 12 x 8
(1219 x 3658 x 2438)
2800 304 Stainless Steel 2899-06-SS call TUI
* Volume of air that must be exhausted from containment room to create adequate negative pressure. Exhaust fan not included; see Exhaust Requirements below.

Dual Purpose HD/Non-HD Compounding Cleanroom
Complies with: USP 797 and USP 800

Sterile-to-Sterile Hazardous Drug Compounding to ISO-800 Requirements
Dual Purpose HD/Non-HD Compounding Cleanroom
ISO 7 Hazardous Drug Compounding Room and ISO 6 Non-Hazardous Drug Compounding Room (with ISO 7 Anteroom)
Nominal Dimensions: W x D x H feet (mm) Exhaust*
(CFM)
Panel
Type
Cat. # Price
Overall Containment
Room
Ante-Room Positive-Pressure
Room
18 x 10 x 8
(5486 x 3058 x 2438)
8 x 10 x 8
(2438 x 3058 x 2438)
4 x 10 x 8
(1219 x 3058 x 2438)
6 x 10 x 8
(1829 x 3058 x 2438)
1800 304 Stainless Steel 2899-00-SS call TUI
18 x 12 x 8
(5486 x 3658 x 2438)
8 x 12 x 8
(2438 x 3658 x 2438)
4 x 12 x 8
(1219 x 3658 x 2438)
6 x 12 x 8
(1829 x 3658 x 2438)
4500 304 Stainless Steel 2899-02-SS call TUI
* Volume of air that must be exhausted from containment room to create adequate negative pressure. Exhaust fan not included; see Exhaust Requirements below.

Hidden Costs of FRP Cleanrooms

Why use stainless steel panels when neither FDA nor USP call for them? The answer is simple: everything else costs more in the long run. We know because we tried.

Although FRP (fiberglass-reinforced) panels may seem an attractive approach to an FDA- or USP-compliant cleanroom, hidden installation and maintenance costs pose significant challenges. FRP panel application, a multi-step process requiring an extended installation schedule, involves specialized adhesive, fast-drying and unforgiving seam sealants, and – most critically – installers with the tools and know-how to apply them uniformly and consistently. Mistakes are costly because re-do is nearly impossible and can require cleanroom shut-down and re-certification. Although Terra installers can avoid these problems, projects outside Southern California require travel and living expenses that can extend for weeks. Working with contractors local to you is a hit-or-miss proposition since most lack experience with cleanroom

FRP projects performed to FDA guidelines. To make matters worse, finished FRP rooms cannot be easily modified, expanded, or repaired if damaged by repeated cleaning and sterilizing.

By contrast, Terra modular BioSafe® stainless steel cleanrooms offer both lower cost of ownership and a showcase facility that simplifies certification to FDA and USP regulations. These pre-engineered, quick-connect panels require no installation expertise; rooms typically go up in a day and offer smooth, easy-clean, durable surfaces. Ease of assembly also means ease of relocation; these cleanrooms can be disassembled and reinstalled quickly and inexpensively. Best of all, as a major steel purchaser and fabricator, Terra can offer its BioSafe stainless steel cleanrooms at the same price previously charged for FRP structures.

Given the hidden costs and installation risks of alternative designs, does anything but a BioSafe stainless steel cleanroom make sense?

Ask the USP Expert

Chris Munoz
Compounding pharmacists face a challenging regulatory environment that is rapidly evolving as state standards move into compliance with FDA and USP mandates. It's important to work with an equipment supplier that understands the complexities of licensing and accreditation procedures.

Schedule a one-hour consultation with Chris Munoz, PharmD to help clarify how the regulations impact your facility and what equipment you are required to use for your compounding activities.

Dr. Munoz teaches pharmacy compounding at the University of Southern California (USC) School of Pharmacy, and serves on the California Pharmacists Association's Policy Committee and Board of Directors. Following Chris's earlier work in compounding pharmacies and for pharmaceutical companies, he began a consulting firm specializing in the business of, and regulatory affairs for, pharmacy compounding.

Chris is an active member of the International Academy of Compounding Pharmacists. He earned his Doctor of Pharmacy degree at the University of Southern California, and his Masters of Business Administration at Chapman University's George L. Argyros School of Business and Economics.

Talk to your Terra Product Specialist to arrange for a private, consultative conversation.

Standard Cleanroom Features:

Status Indicator

Important Note: Modular cleanrooms do not include floors; they are designed for installation on a flat, sealed, non-particulating, crevice-free surface, which can be caulked to the clean room frame to form a seal. Coved vinyl flooring can be added as an optional feature.

Status light provides clear indication that fan filter units
are in operation.

Exhaust Requirements: Containment requires a customer-furnished dedicated in-house exhaust system capable of pulling the air volume indicated on ordering charts below. Terra provides a chemical-resistant polypropylene exhaust manifold to deliver air removed from the room to one or more exhaust flanges, typically located near ceiling height for connection to a roof-mounted exhaust system.

If no such system exists, Terra will work with your facilities staff to provide the appropriate exhaust fan. Cleanrooms that include a biosafety cabinet may require an additional dedicated exhaust line.

Depending on hazardous material(s) that may be present in the exhaust flow, you may require additional filtration before exhaust air can be released into the environment. Terra recommends consulting a validation specialist or resources provided by the American Society of Health-System Pharmacists (ashp.org) for guidance.

Air Return illustration

 


BioFit® Urethane Chairs and Stools

2806-57
Model No. 28006-57
  • Comfortable, washable performance complies with USP aseptic requirements (ISO 6)
  • Damage resistant to water, lubricants, chemicals, inks, paints, coatings, and resins
  • Ergonomic seating with adjustable backrests and seat heights
  • Chair and stool models available in a range of seat heights
  • Comes with rolling casters or foot glides
  • More information about Urethane Chairs and Stools

Door and Window Options


window
Automated Sliding Doors
A no-touch motion sensor opens sliding door for passage into or out of the clean room. Get single or double doors to transport personnel and carts with hands-free operation. Sliding doors conserve forward space and close automatically to preserve pressure and cleanliness within the controlled environment. Urethane wheels stay locked in upper and lower tracks to ensure smooth sliding, and a microprocessor monitors door position to adjust speed of movement and braking. Visit Automatic Sliding Door Systems for more details and ordering information.

window
Automated Swing Door Opener
For hands-free door opening when side-to-side space may be an issue, opt for Terra’s Automated Swing Door Opener. The space-saving unit fits above the swing door; trigger the door motion with the swipe of a hand in front of the sensor pad. Operation is quiet and open/close speed is programmable. An on-board power supply eliminates the need for secondary power. This opener can be installed on single or double doors, and is ADA-compliant. Visit Automatic Swing Door Opener for more details and ordering information.

 


window
Tempered Glass Window
The 0.5" double-paned tempered glass window is secured between two 304 stainless steel retaining frames; the internal frame has no fasteners or other cleaning obstructions. Standard size: 47"W x 36"H (nominal); specify other desired size.

  Cat. # Price
Tempered Glass 6600-45A Price
Fire-Rated Glass 6600-46A Price

® Magnehelic and Digihelic are registered trademarks of Dwyer Instruments.


File Type File Name Publication Date
Video USP Cleanroom Construction
Time-lapse video showing the installation of a 6' x 10' USP 797 multi-chamber cleanroom. Swing door, windows, flooring, control panel, and ceiling components, including fan/filter units and lighting, are shown.
12/08/2014
Video BioSafe® Pass-Throughs
Showing the optimal cleanroom pass-through chamber for aseptic operations, this video provides an overview of the features and benefits of BioSafe pass-throughs.
05/14/2015
Tech Resource (PDF) Calculating Clean Room Cleanliness: How many FFUs and Lights?
This tutorial provides practical tips for correlating the desired cleanliness level (per ISO/FS209 standards) to the required number of fan/filter units (FFUs). Also provides guidelines for specifying lights based on the type of operations being conducted.
05/15/2015
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