Download - Piramal Critical Care
Best Management Practices and Compliance November 4, 2016
Joe Monkiewicz – EHS Manager
Piramal Critical CareAnesthetics Facility Bethlehem, PA
PCC Bethlehem – Agenda
• “What should I talk about?” • Piramal? – Where is it and what do they do?• Permit / water usage overview – Need to understand before you can manage.
• Best Management Practices – Doing some good things.• Our look to the future – All feedback welcome on this one
• Failures and learnings – Hope it helps• Questions
PCC Bethlehem – Manufacturing Facility and Corporate Offices
Piramal Manufacturing
PCC Bethlehem Manufacturing Site
• 25,113 ft2 Bulk Manufacturing Facility• Site has been making anesthesia since ~ 1991 (Inhalon Pharmaceuticals)• Industry icon Ross Terrell, was a co-founder of Inhalon and worked at site until 2004
• 22,000 ft2 site expansion completed in 2012• Includes state of the art packaging line, stability chambers and warehouse
• Piramal acquired business from Minrad in 2009
IsoBulk production ended 2014
Sevo
Des
Primary product, production focus
Development Launch 2017
General Plant Information
• We manufacture, package, sell, and distribute inhalation anesthetics, and are the third largest producer in the world
• Our products are used on humans and animals
• ~140 total employees
• Sales & distribution to over 110 countries around the world, on 6 continents
• 24/7 Manufacturing Operations
PCC - #3 Fastest Growing Business in Lehigh Valley in 2014
PCC Bethlehem – Manufacturing Facility and Corporate Offices
PCC Bethlehem – Industrial Wastewater Permit
• PCC – Bethlehem operates under Industrial Waste Discharge Permit No. 039– Effective: September 29, 2015– Expiry: September 29, 2018
• Authorized wastewater discharge• Thermal oxidizer quench water• Sanitary Facilities
• Effluent Limit Overview‐ pH No lower than 5.0 and not greater than 11.5‐ Temperature discharge limit no higher than 150 °F ‐ Organic control
PCC Bethlehem – Manufacturing - Effluent Limits (Local Limits)
• pH (5.0 to 11.5)• BOD (Monitor Only)• COD (Monitor Only)• TSS ( Monitor Only)• Nitrogen, Ammonia (Monitor Only)• Copper – 1.35 mg/l• Chromium – 0.91 mg/l• Nickel – 1.36 mg/l
• Sample twice per year / 24‐ hour composite• Sample Location – Facility Manhole (Plant Entrance)• Reports due June 1 and Nov 1
PCC Bethlehem – Manufacturing - Effluent Limits (Categorical Limits)
• Title 40 → Chapter I → Subchapter N → Part 439 PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY
– Subpart C—Chemical Synthesis Products ‐ Pretreatment standards for existing sources (PSES).
• 23 Chemicals Sampled • Maximum Daily Limit (mg/l)• 30‐Day Average (mg/l)• Sampled twice per year / grab samples • Sample Location – pH Adjustment Tank (pHAT Tank)• Reports due June 1 and Nov 1
** City of Bethlehem – Performs Quarterly Sampling (in addition to the Piramal Sampling)
Water Balance - Based on Metered Usage
• Approximate gallons used annually – ~11 million gallons– Thermal Oxidizer ‐ 46% (Sewer)– Cooling (Cooling Tower / Process) – 43% (Evaporative losses)– Process Wastewater – 7% (Offsite Disposal)– Hydrochloric Acid (Process Absorbers) – 1% (Offsite Disposal)– Sanitary (Sinks, toilets, showers, cleaning) – 3% (Sewer)
PCC Bethlehem – Manufacturing Facility – Best Management Practices – Water / Organic Separator