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