Precise & Reliable Containment Risk-based containment for OSD's and intermediates acc. to ECHA
Precise & Reliable risk-based containment for Occupational Hygiene
HSE – regulations unleashed a sequel of measure to be taken by operating companies to overall minimize the direct and indirect exposure of employees and environment to toxic compounds. Following the factual differences in tackling risk-based occupational hygiene, hence containment requirements, TRM Filter follows a three layered solution approach:
Reliable and precise engineering of all functional aspects with very highly hazardous and extremely hazardous High-Potency APIs (HPAPIs) (OEB 5 & 6)
The OEL's of HPAPIs themselves are exceeding the protection levels of most singular containment provisions. A risk-based assessment along ISPE baseline 7 in implementation of ICH Q9 is advisable to determine target protection in all handling aspects in a practical fashion. Focal attention is given to the assessment of the OEB's of real, often diluted process dusts under due consideration of dust migration and other transport issues that separate powder fractions. Optimization of the allocation of the deduster within the process, the logistics of its cleaning, the identification and early recognition of failures and their effects are further issues in defining dedusting filters in these applications. TRM Filter communicates with stakeholders on all of these concerns and defines the detail of its Maximo configuration for a precise and reliable dedusting filter solution.
Safety with comprehensive solutions for hazardous and highly hazardous APIs (OEB 3&4)
Safety in dedusting filter systems with OEB 3&4 levels can be ascertained by standardized configurations. Exemplary containment qualification by APCPPE (Assessing the Particulate Containment Performance of Pharmaceutical Equipment), earlier called SMEPAC, becomes confirmed by ICH Q9 operating qualification in the operating company's organization. For fully continuous operations Optimo addresses all relevant funcionality at OEB 4, for semi-continuous operation Practico is protected at OEB 3 level.
Safe, yet inexpensive upgradable systems for preventative protection against estimated occupational hygienic hazards (ECHA strategy 3 & 4)
With industries handling other dusts of typically uncertain but suggestible toxicological impact, we predominantly experience the ECHA requirement for closed isolators (strategy 4), similar to OEB 3 requirements met by Practico. Where there is no toxicological indication to a substance's harm, ECHA requirements for open isolators (strategy 3) is mostly pursued and simple protection means are implemented into Novento. TRM Filter's most economic Enduro is an unprotected dedusting filter system equipped with provisions for a life long upgrade to a closed isolator. As the depth of knowledge of toxicological hazards with chemicals is bound to increase with evolving and intensifying REACH, Enduro is your safe bet to a sustainable dedusting filter system investment.