Late last year, the US experienced a fungal meningitis outbreak rated as epidemic that spread across 20 states. It was caused by contaminated epidural steroid injections prepared in a drug compounding pharmacy in Massachusetts.
As Florida was one of the most affected states, its Department of Health (DOH) and Board of Pharmacy recently approved draft legislation that regulates the preparation of drug formulations, parenterals and mixtures in compounding pharmacies. One of the key aspects addressed by this amendment is where and under what specific conditions compounding centres will be allowed to prepare parenteral injections or mixtures and which regulations must be complied with by the facilities destined to be used for compounding purposes as well as during the compounding process itself.
Pharmacies are therefore required to prepare all their compounded drugs in cleanrooms that meet the same FDA regulations that apply to large-scale pharmaceutical production and also to follow the recommendations listed in the GMPs and hospital regulations in force.
Stricter legislation is also emerging in Europe; Germany is leading the reform with the 35th paragraph of the Ordinance on the Operation of Pharmacies (§35 Apotheken-betriebsordnung) that focuses on the preparation and compounding of parenteral drugs and cytotoxics. This amendment came into force on 12 June 2012 with a period of transition and implementation of up to two years. Compounding pharmacies are required to carry out the preparation of both parenterals and cytotoxics in cleanrooms that comply with the same regulations and GMPs as the pharmaceutical industry.
In response to these legislative changes, AIRPLAN, a group based in Spain and the US specialising in the design and execution of cleanroom turnkey projects, has developed a solution that was officially launched to the US market at the MD&M Trade Show in March. The Quick Box is a ready-made cleanroom, contained in powder-coated galvanised steel modular panels, specially designed as a compounding facility for facilities with limited space.
The Quick Box is available in three standard models designed for the preparation of cytotoxics, parenteral solutions and intravenous mixtures or the formulation and repackaging of drugs. Each Quick Box corresponds to the required classification (ISO 8 to ISO 5B are available) and can be complemented with the necessary accessories for each case. Sizes range from 4.73m2 to 16m2 (51ft2 to 170ft2), according to the chosen application.
The Quick Box is the easy way to install a cleanroom in an existing facility to comply with official regulations without investing in civil engineering.
