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  2. Sterile/Non-Sterile Compounding (USP-795, USP-797, USP-800)

Sterile and Non-Sterile Compounding to USP-795, USP-797 and USP-800

 
Model shown: No. 2900-74 with three additional windows,
furnishings and ISO 5 glass WhisperFlow hood (not included)
  Typical USP-795 non-sterile preparation configuration,
including biosafety cabinet, laminar flow hood and incubator

USP (United States Pharmacopeia) oversees compounding, or preparation, of prescription drugs in clinics, hospitals and pharmacies. Compounded drugs are not mass-produced, but rather mixed from ingredients in specific doses for individual patients. USP chapter 795 covers the regulations for non-sterile drug compounding, forms of which include ointments, salves or liquid versions of drugs typically sold as tablets. USP 800 outlines the requirements for mixing hazardous drugs (sterile or non-sterile); common example of these are chemotherapy drugs or radiopharmaceuticals.

Sterile drug blending, regulated under the USP 797 chapter, is the third category of compounding. Compliance is critical, and aseptic practices benefit both patients and technicians; bacterial, viral or fungal contamination can affect safety and efficacy. Preparations such as total parenteral nutrition (TPN), drug infusions and antibiotics injections are examples of sterile medications mixed in a compounding pharmacy.

Aseptic procedures require specialized equipment. Terra designs cleanrooms to meet USP’s specified ISO 8 for ante-rooms and ISO 7 for buffer rooms, and provides Primary Engineering Controls (PECs) such as compounding aseptic isolators and laminar flow hoods that certify as ISO 5 environments. During the sterile preparation, labs also need supplies and equipment to store, handle, and package drugs, as well as dispose of waste and used materials. Terra’s products meet the needs of these strict protocols, helping healthcare facilities to stay in compliance. Visit this USP/cGMP resource page for information including a Terra webinar presentation and USP cleanroom design white paper.

For USP 800-compliant pharmacies, Terra offers compounding aspectic containment isolators (CACIs) for compounding sterile preparations (CSPs) carrying beyond use dates (BUDs) of 12 hours or less. For pharmacies compounding hazardous drugs, Terra designs USP 800-compliant modular cleanrooms and furnishes the rooms with Class II B2 biosafety cabinets, BioSafe pass through chambers, ISO 5 work stations and an array of cleanroom-compliant equipment. Terra offers dust cabinets, mills, grinders and variety of dispensers for pharmacies performing non-sterile compounding in USP 795-compliant facilities.

Sterile and non-sterile compounding require specific equipment and filtration. The products featured here were selected to help your purchasing efforts: ISO-rated rooms, isolators and hoods for safe operation; instruments and storage cabinets for successful formulation; and garments, wipes and flooring options to keep the area free of contaminants.

Chris Munoz
Ask the Expert: Chris Munoz, PharmD
Principle Consultant at ITL Consulting
Compounding pharmacists face a challenging regulatory environment that is rapidly evolving as state standards move into compliance with FDA and USP mandates. Because licensing and accreditation procedures differ from state to state and from year to year, it’s important to work with an equipment supplier that understands these complexities.

When you work with Terra, you work with Chris Munoz, PharmD, a leader in the field of pharmaceutical compounding. Customers can schedule a one-hour consultation with Dr. Munoz to have him help clarify the impact of the regulations on their business. Talk to a Terra Product Specialist to request a dialogue. 

More . . .

 

Cleanroom & Accessories

USP 797 Clean Rooms

USP 797 Clean Rooms

Our USP 797 rooms meet the requirements for compounding sterile pharmaceutical preparations in an ISO-rated controlled environment

USP 800 Clean Rooms

USP 800 Clean Rooms

Negative-pressure environments meet USP requirements for compounding hazardous drugs. ISO-rated clean rooms ensure safe sterile or non-sterile applications.

Automatic Sliding Doors

Automatic Sliding Doors

Automatic, hands-free doors give you speed and efficiency when entering or exiting the cleanroom. Glass panels are easy-to-clean and provide visibility

Automatic Swing Door Operator

Automatic Swing Door Operator

Install in Terra’s Smart Pass-Through Chambers and modular cleanroom doors; space-saving module has 12 programmable options including hands-free opener

USP 797 Sinks by Eagle

USP 797 Sinks by Eagle

Pedestal mount 304 stainless steel sinks available in foot valve or electronic-eye sensor models for hands free operation inside a cleanroom anteroom

Hands-Free Sink and Hand Dryer

Hands-Free Sink and Hand Dryer

Stainless steel or polypropylene hand and glove washing/drying stations incorporate washing and ULPA-filtered drying modules in a fully-integrated system

PureDry Hand & Glove Dryer

PureDry Hand & Glove Dryer

Dry hands, gloves and lab supplies with warm, ULPA-filtered particle-free air. Clean, brushless motor ensures reduced noise and vibration

Compounding Isolators & Hoods

USP 797 Compounding Aseptic Isolator

USP 797 Compounding Aseptic Isolator

Compounding Aseptic Isolator (CAI) is designed to meet USP 797 requirements; pressure gauges monitor the two chambers, and HEPA filtration provides clean, laminar airflow

VersaFlow Laminar Flow Compounding Aseptic Isolator

VersaFlow Laminar Flow Compounding Aseptic Isolator

Converts into a vertical laminar flow station, meets USP 797 and ISO Class 5; ideal for I.V. compounding in pharmacies

LFGI Laminar Flow Glovebox/Isolator

LFGI Laminar Flow Glovebox/Isolator

Ideal for pharmaceutical compounding, CACI and CAI units exceed NIOSH and meet USP 797 standards; use as positive- or negative-pressure chambers

LFGI Radiopharmacy Isolators

LFGI Radiopharmacy Isolators

Lead-shielded Compounding Aseptic Containment Isolators protects technicians and meets USP 797 requirements; fits most major brand dose calibrators

Purifier Logic+ Class II, Type B2 Biosafety Cabinet

Purifier Logic+ Class II, Type B2 Biosafety Cabinet

Discharges 100% of filtered exhaust air from work area via a dedicated exhaust system and remote blower; models need to be hard ducted to the outside

WhisperFlow™ Hoods

WhisperFlow™ Hoods

Convert any bench into an ISO-rated laminar flow station with this versatile, quiet hood. Pick the air flow direction and material suited to your application

RXPert Single Filtered Balance Enclosure by Labconco

RXPert Single Filtered Balance Enclosure by Labconco

USP 800-compliant Class I balance hood for non-sterile compounding and powder weighing with hazardous drugs; must be externally vented

Equipment & Furnishings

Entris Analytical and Precision Balances

Entris Analytical and Precision Balances

Economical user-friendly balances feature an easy to read display, monolithic weighing and built-in applications for standard lab weighing applications

Hot Plate, Stirring Hot Plate, and Magnetic Stirrer<br>by Benchmark Scientific

Hot Plate, Stirring Hot Plate, and Magnetic Stirrer
by Benchmark Scientific

Compact units feature a durable, chemical-resistant, ceramic-coated stainless steel top, convenient microprocessor controls with turn knobs, and LED indicator lights

Rubbermaid Medical Waste Step-On Containers

Rubbermaid Medical Waste Step-On Containers

Sturdy plastic 4.5- to 30-gallon capacities are designed with tight-fitting lids, leak-proof bottoms and quiet pedals for hands-free medical waste collection

Utility Carts

Utility Carts

Utility carts are equipped with convenient handles, easy-to-roll casters and wire or solid shelves. A patented design allows height adjustment

Revco Pharmacy Refrigerators

Revco Pharmacy Refrigerators

Revco Pharmacy Refrigerators feature stable temperature control from 1° to 8°C, digital operation, LED Lighting, stainless-steel drawers, & audible alarm.

Cleanroom Vacuum Cleaners

Cleanroom Vacuum Cleaners

See our full line of cleanroom and lab vacuum cleaners: stainless steel, HEPA- and ULPA-filtered, explosion-proof, wet/dry, portable, and more!

Supplies

Anti-Fatigue Floor Mats

Anti-Fatigue Floor Mats

Work more comfortably with these spongy mats that are resistant to microbes and chemicals. Other options include ESD and double-thick

Valutek Sticky Mats

Valutek Sticky Mats

Adhesive mats, with removable layers. are simple yet effective in cleaning dirt from foot traffic and cart wheels prior to entering clean areas

Face Masks from Dupont

Face Masks from Dupont

This comfortable, breathable mask excels at filtration and barrier protection, giving you peace-of-mind in your controlled environment

Taffeta Cleanroom Frocks

Taffeta Cleanroom Frocks

Knee-length Taffeta frocks are comfortable, long wearing and modestly priced. They resist snagging and have stainless steel snap closures

Disposable Gloves

Disposable Gloves

Disposable nitrile and PVC gloves are ideal for multiple cleanroom applications & cleanliness levels. The PVC glove has excellent ESD properties

Cleanroom Wipes

Cleanroom Wipes

Lab and cleanroom wipers made by Valutek are designed to clean spills and messes without leaving residue, such as fibers, behind

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