Always dedicated to answering the needs of the marketplace, Penn now offers High Containment Operations for manufacture of high potent drugs. There is a global shortage of High Containment Operations (HCO) manufacturing facilities for highly potent drugs despite a growing number of pharmaceuticals containing highly potent active ingredients including hormones, cytotoxic drugs, prostaglandins, retinoids, some antibiotics and some narcotic substances. Highly potent drugs are pharmacologically active in humans at doses of 1mg or less and require special containment during processing, as defined by the OEL (occupational exposure limit) or OEB (occupational exposure band) assigned for the product.

As defined by OELs (occupational exposure limits), it is estimated that approximately 45-50% of product OELs that are now being set by the pharmaceutical industry are at ≤10mcg/cu.m (OEB4).

Penn's HCO facility offers high containment facilities to pharmaceutical companies conducting clinical trials requiring small scale batches of highly potent drugs. From this service clients can expect:

• Class 100,000 containment manufacturing room - negative pressure, double airlock, single-pass HVAC, safe-change EU 13 HEPA filters
• Conforms to ISO Class 8 (100,000) BS EN ISO 14644-1 (1999) & EU GMP volume IV
• Closed manufacturing system
• Isolator for dispensing highly potent API
• ChargePoint valves for contained transfer of API (powder or solution) to a Zanchetta P10 one-pot high shear mixer/granulator/dryer.
• Further contained transfers to milling & blending stages if necessary
• Contained transfer to tablet press
• Batch sizes up to 10L/3-6kg
• Validated to OEL >1<10mcg/cu.m, OEB 4
• Primary packing in separate class 100,000 containment room

• High Potency Flyer (pdf format) (348k)