BSP Pharmaceuticals has well thought out, designed and created its plant to manufacture only antineoplastic products. The facility and equipment were conceived in a special way by an integrated team through an innovative approach: the plant has been built to assure full containment for the development, manufacturing and control of cytotoxic and cytostatic products.
The “full containment” philosophy has been applied to all the aspects of the product cycle through the use of isolator technology; more than 25 isolators and RAB (Restricted Access Barrier ) are operative in the plant.
This kind of philosophy allows to achieve the best operative condition for people by respecting the environment.
Health
- The plant has been designed to provide an Occupational Exposure Limit (OEL) below 10ng (nanograms/cubic meters)/m3 as primary containment.
- Our people work without personal protection devices due to such OEL.
- Containment is granted by insulating systems (Isolators & RAB) focusing on quality of the air. The personal protection is a plus.
- Such OEL can be furthermore reduced thanks to the secondary containment where environmental parameters are continuously monitored and alarmed.
- Medical surveillance is regularly performed by a physician in order to monitor the personnel health.
Environment
- Contaminated liquid or solid wastes generated by cleaning operations are collected in a segregated sewer and stored in dedicated tanks, to be chemically treated before incineration.
- All exhaust air is filtered before its expulsion.
- All environment issues are managed according to local authorizations.
Safety
- Antineoplastic products are handled only by highly qualified and constantly trained personnel.
- Risk assessment is available and BSP has Safety Standard Operating Procedures which allow the monitoring of risks and the prevention of accidents.