Grifols Misterium® Cleanroom Solutions Expands to Include Revolutionary Decontamination Air and Surface Disinfection Systems for Pharmaceutical Preparation


  • Grifols is the exclusive U.S. distributor for the airinspace portfolio of solutions to control contamination in existing cleanrooms, segregated compounding areas, and temporary cleanrooms
  • Grifols Misterium® cleanroom portfolio is enhanced by the addition of airinspace systems, offering a more complete solution to hospital pharmacies and compounding centers striving for compliance with United States Pharmacopeia Chapters <797> and <800>  

Barcelona, Spain, December 4, 2017 – Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and provider of sterile compounding-related technologies and services for hospitals, clinics, and compounding centers, has reached an exclusive agreement with airinspace to distribute mobile air decontamination systems and protective environment solutions for healthcare settings. Together with Grifols Misterium cleanroom solutions and operational consulting services, the distributorship with airinspace offers customers a more complete solution for mobile cleanroom technology.

Cleanrooms require strict control of environmental pollutants and must be designed and operated in compliance with relevant industry guidelines and regulations to ensure the safe preparation of compounded medications. To comply with United States Pharmacopeia (USP) Chapters <797> and <800>, many hospitals realize that changes or renovations to their current compounding environments are necessary. Aging infrastructure, deteriorating materials, uncontrolled air streams, improper filtration, and contaminated systems can compromise the environment by introducing opportunities for cross contamination, poor cleanability, and critical leaks.

"A fully compliant compounding pharmacy program starts with an adequate environmental analysis and the proper design and construction of primary engineering controls," said Juan Miguel Cana, General Manager for North America Sales of Grifols Hospital Division. "Designing and building a cleanroom can be challenging on many levels. Continued operation is essential, but construction is a dirty job, and cleanroom environments must be protected and continuously monitored. Together, Grifols and airinspace help healthcare institutions complete this transition to USP compliance with our robust portfolio of cleanroom solutions."

The airinspace PLASMAIR® air decontamination unit with HEPA-MD® offers unique and proprietary technology, which is validated to destroy a full spectrum of airborne microorganisms. The technologies augment the effectiveness of existing cleanrooms and segregated compounding areas, as well as serve as air quality control mechanisms in temporary cleanrooms during pharmacy renovations.

The airinspace HPVPA disinfection system diffuses a cold hydrogen peroxide and peracetic acid solution to destroy bacteria, spores, fungi and yeasts, viruses and mycobacteria, including Myobacterium tuberculosis.

About airinspace®

The airinspace company provides customers with expertise, audit, and smart solutions to control microbial, particle, and chemical contamination in hospitals and critical areas.

Airinspace develops, manufactures, and supplies a unique range of air purifiers and solutions for protected environments. 

  • PLASMAIR® embedded, patented HEPA-MD® technology, capable of the destruction of microorganisms and the removal of particles, chemical molecules, and volatile organic compounds (VOCs)
  • HEPA high efficiency filtration units
  • eCHEM for the removal of airborne chemicals and VOCs

Airinspace also created a mist fogging technology for surface disinfection HPVPA as a highly effective process for infectious outbreak containment, disinfection of airborne infection isolation rooms (AIIRs), and preparation of protected environments for immunocompromised patients and critical applications.

About Grifols Hospital Division

Grifols Hospital Division aims to take pharmacy technology and service to new levels of flexibility, proficiency, and accuracy with Grifols i.v.TOOLS®, a suite of scalable products and services designed to help meet the needs of pharmacies for safety, efficiency, and regulatory compliance during compounded sterile preparation production. i.v.TOOLS® includes:

  • KIRO® Oncology and KIRO® SP robotics for automated compounding of sterile preparations
  • Misterium® cleanrooms, equipment, and engineering services
  • Phocus Rx® IV workflow management systems
  • Gri-Fill® semi-automated compounder
  • DOSI-FUSER® single-use, continuous-infusion devices

NOTE: This press release is intended for the U.S. market only.