Large clinical-scale cleanroom operations for T cell therapies often use a class ISO 7 (Class 10,000) cleanroom room environment with an ISO 5 (Class 100) biological safety hood as a primary engineering control. An ISO 7 cleanroom requires an average airflow velocity of 10-15 ft/min with 60-90 air changes per hour.
Minncare and Actril are two examples of cold sterilants used for endoscope, dialysis, and cleanroom disinfection. Both are authorized as Class A sterilants by the EPA. Cold sterilants provide non-invasive sterilization of dental/surgical equipment such as pressure clamps, tubing clamps, blood pressure cuffs, mirrors, etc.
A cleanroom air handling unit (AHU) is a cornerstone of temperature, humidity, and pressurization within controlled environments. Today, modular fan filter units allow more adaptable configuration with simplified maintenance procedure. Both systems serve conditioned and filtered air throughout a cleanroom facility.
Our friends at Simco-Ion sent us this brilliant guide to ESD cleanrooms design, principles, and other considerations. Download the PDF you’ll find case studies and technical information about how static charges influence particle retention and impact manufacturing outcomes in controlled environments. Below we’ve highlighted important ideas in relation to medical device cleanrooms and provide additional resources.
For communication satellites that remain within earth’s orbit, an ISO Class 6-8 cleanroom allows sufficient particle and contaminant control. Cleanroom engineers design each space so that particles from production surfaces are whisked away from critical components. A combination of softwall production areas and hardwall cleanroom facilities provide isolation of critical tasks.
For ISO 14644 compliance, all particle counting equipment requires a calibration certificate.
ISO 13485 is designed for use throughout the life cycle of a medical device. It supports each stage of medical device development and operation from initial concept to production and disposal. The standard helps internal and external parties certify and validate processes which maintain the stability of quality management systems (QMS).
Are the terms sterile and aseptic used interchangeably? Is a cleanroom sterile? What is aseptic processing?
Vileda Professional Cleanroom Mops support most critical applications. Each Vileda mop head, frame, or bucket connects over 30 years of development for controlled environments and healthcare. Find stainless steel mop sets and handles, or ask about quantity discounts on Vileda mop refills, pads, and accessories. Join St. Johns and other leading healthcare organizations for enhanced sanitization within controlled environments, cleanrooms and healthcare facilities.
USP 800 is a cleanroom standard issued in March of 2014 by the United States Pharmacopeial Convention (USP). The deadline for compliance may change, at the time of this articles publication the deadline is scheduled for December 2019. The date and scope of adoption may differ on a state-by-state basis, thus consulting with a compliance specialist is encouraged.
Pre-engineered fabrication consolidates scheduling with minimal disruption and fewer variables. Difficult or expensive upgrades avoid overbearing noise, construction artifacts, and minimize if not eliminate the burden on facility staff for project management.
USP Chapter 797 cleanroom design requires that facilities pressurize non-hazardous compounding and storage areas. ISO 5, 7 and 8 environments support primary engineering controls, buffer rooms, and ante-rooms.
New USP guidelines may present challenges for compounding facilities. Some facilities need infrastructural and mechanical modifications for compliance. System evaluation includes duct systems, HEPA fan filters, differential pressure standards, air monitoring, and external air exhaust equipment.
Facilities unpacking hazardous drugs within a negative pressure room do not require procedural changes to meet USP unpacking area requirements. Facilities unpacking HDs within positive pressure ante rooms or facility spaces will require reconsideration.
The definitive cleanroom and sterile compounding glossary. Learn terminology and definitions for USP 797 and USP 800 compounding.
Definitive Cleanroom Construction FAQ: How much does a cleanroom cost? How does the level of ISO classification impact build and operating costs? How much supporting space will I need for a cleanroom addition or ISO class upgrade? What’s the advantage of a turnkey cleanroom system?