SECTION A: GENERAL FACILITY INFORMATION
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| Janssen Ortho LLC
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| Johnson & Johnson
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   | Mr. Sandy Casillas |
   | Environmental Supervisor |
   | 787-272-7413 |
   | 787-272-7435 |
   | scasill2@janpr.jnj.com |
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   | Road 933 KM 0.1 Mamey Ward |
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   | Gurabo |
   | PR |
   | 00778-9629
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   | HC 02 Box 19250 |
   | Mamey Ward |
   | Gurabo |
   | PR |
   | 00778-9629 |
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| http://www.janssen.com
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| More than 1,000
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| 334514
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| Yes
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A new manufacturing area was added were the product "Paliperidone" is manufactured
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| Yes
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We now store acetone and waste acetone in bulk. A Leak Detection and Repair (LDAR) program is required under the Resource Conservation and Recovery Act.(RCRA). Also, we submitted the Title V air emission application permit triggered by NOx.
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| 2006
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ISO 14001 |
This surveillance assessment included: Environmental Aspects,Legal & Other Requirements, Objectives Targets & Programs, Resources Roles Responsibilities & Authority, Documentation, Control of Documents, Operational Control, Emergency Preparedness & Response, Control of Records & Management Review.
| October 2006 |
ISO 14001 |
This surveillance assessment included:
Environmental Policy, Environmental Aspects, Objectives Targets and Programs, Competence Training & Awareness, Communication, Operational Controls, Monitoring & Measurements, Evaluation of Compliance, Nonconformity Corrective and Preventive Action, Internal Audit & Management Review | February 2006 |
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| 2005
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| The next internal EMS assessment is schedule for 4th quarter 2007
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| 2006
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A compliance audit was performed to verify compliance on report, permits, sampling events as part of ISO pre-assessment. | February 2006 | Performed by Eng. Lymaris Delgado, (staff), Eng. Marla Ciares (third party) and Eng.Charlotte Poulet (third party) who is an Environmental Professional at Ortho Biologics in Manati (PR) |
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On 03-07-06 We receive an inspector from EQB (PR) to conduct compliance inspection verifying 90 days storage area, satellite areas, manifests and other documents
On 03-13-06 We receive an inspector from the POTW (Pre-treatment Program) to conduct a compliance inspection. The WWTP was inspected and documents were requested.
On 05-04-06 We receive Mr. Adalberto Bosque from EPA (CFO) as part of the Remediation Project under the Superfund Program.
On 06-06-06 We receive an inspector from DOH to conduct a sampling on our drinking water system.
On 07-17-06 We receive an inspector from the POTW (Pre-treatment Program) to conduct a sampling of our WWTP discharge.
On 09-12-06 We receive an inspector from DOH to conduct a sampling on our drinking water system.
On 09-22-06 We receive an inspector from the POTW (Pre-treatment Program) to conduct a compliance inspection. The WWTP was inspected and documents were requested.
On 10-04-06 We receive an inspector from Natural Resource Dept.(NRD) to verify compliance with the wellwater franchise permit.
On 12-12-06 We receive two inspectors from EQB Superfund Program to supervise the sampling activities at the remediation project.
On 12-19-06 We receive an inspector from DOH to conduct a sampling on our drinking water system.
No violations were found during these goverment inspections.
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To reduce risks on potential spills of acetone we have modified the unloading approval procedure and as a result we have reduce the unloading waiting period from 3-4 days to 24-36 hrs.
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| No
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Of the latest ISO 14001 assessment there is one pending non-conformance item that is schedule for completion. Based on a potential spill scenario at the acetone tank farm, it was recommended a modification of the containment area for the unloading process. A capital apropiation request was routed for approval and construction/completion is schedule for 3rd quarter 2007.
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| November 06 |
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| Mr. Ivan Cartagena |
| General Manager |
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| Yes
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| No |
Janssen Ortho LLC's first commitment is to reduce the facility's total water use. |
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We continued to reuse water from remediation project in our utilities such as cooling towers therefore avoiding potable water consumption. We also initiated the wastewater treatment plant water reuse project, which will allow us to reuse most of the WWTP discharge and consequently reducing the potable water usage. Normalization Factor is based on 4804MM Units produced in 2006 vs 4755MM Units produced in 2003 |
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Approximately 40% of water discharge of the remediation treatment system have been reused internally for non-potable purposes. In addition, several projects (e.g., monitoring of water usage at different areas) and/or initiatives addressed to the reduction in water consumption were implemented. |
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Approximately 40% of water discharge of the remediation treatment system have been reused internally for non-potable purposes.
In addition a revision of the water bills revealed that JOLLC was paying various invoices of facilities formerly use by Janssen. Various accounts were cancelled and credits received from the actual users.
Normalization factor is based on 4755 MM Units produced in 2003 vs 5111 MM units produced in 2004. |
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Janssen Ortho LLC's second commitment is to reduce the facility's materials use. This data is aggregated with that of three other PSGA manfucturing facilities (Ortho Pharmaceutical and Ortho Biologics of Manati, PR and Ortho Pharmaceutical in Raritan, NJ). The data is included in the report for the Raritan facility. |
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The facility established a goal for 2007 on the EI metric and was agreed on by the facility's leadership group. This metric is presented on the staff meetings. Normalization factor is based on 4755 MM Units produced in 2003 vs 4804 MM Units produced in 2006 |
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Site is focusing in the Design for the Environment (DfE) approach required by Johnson & Johnson for Planet 2010 Goals and the Efficiency Index (EI), which is a metric that takes into consideration the handling of materials received, quality control effective techniques/practices, manufacturing processes, storage of final products, etc. These practices and programs have been integrated within the Process Excellence initiatives. These initiatives seek for opportunities on process improvement, increase yield, reduce cycle time, control employee exposure and operating costs. Controlling all those have a positive impact in the site environmental performance. The Site's EI for Year 2005 was one of the highest's within the organization. |
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Site embraces the six sigma, lean thinking and design excellence approach. It is basically been integrated within the Process Excellence initiatives. This initiative seeks for opportunities on process improvement, increase yield, reduce cycle time, control employee exposure and operating costs. Controlling all those have a positive impact in the site environmental performance. Projects that have impact this goals are: Granulators yield improvement by 2-5%, Improvement in compressors stage thus eliminating rejects due to broken tablets, Automation of packaging lines, etc.
Normalization factor is based on 4755 MM Units produced in 2003 vs 5111 MM units produced in 2004.
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Janssen Ortho LLC's third commitment is to reduce the facility's generation of non-hazardous waste. |
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Disposable protection garments at the manufacturing area were replaced by reusable ones. This was part of a greenbelt project were cost avoidance was impacted significantly. Another activity for waste reduction is the reuse of empty fiber drums at other J&J facilities therefore avoiding discarting them. Normalization factor is based on 4755 MM Units produced in 2003 and 4804MM produced in 2006
Note: Waste to landfill for 2005 changed from 275,640 lbs to 1,095,630 lbs. |
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The site is identifying and implementing reuse and recycling processes that are helping the achievement of the reduction of non-hazardous waste disposal. In addition, since the Efficiency Index and the Design for the Environment initiatives are being implemented, this have aid in the reduction of waste associated with raw materials and others that indirectly are associated with the disposal of discarded materials (e.g., plastic bags, drums). |
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Although a slight increase in the overall volume of waste was experienced during this year, site made significant efforts in manageing the waste through environmental-friendly management methods. Over 45% increase in recyclables materials compare with year 2003. Overall waste managemet practices represents that 35.04% of our non-hazardous waste is managed by preferred management method as described by J&J (i.e. reuse, recycle, incineration with energy recovery, etc.)
Normalization factor is based on 4755 MM Units produced in 2003 vs 5111 MM units produced in 2004. |
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Janssen Ortho LLC's fourth commitment is to reduce the facility's generation of hazardous waste. |
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We provide continuous awareness on waste minimization practices, pollution prevention and waste segregation as part of the orientations we provide to employees handleing HW. |
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A reduction in hazardous waste was due to the implementation of the Design for the Environment tool, the Efficiency Index, and the practice of weighting the materials instead of use the volumes of the different containers.
DFE is a systematic process to identify and minimize the environmental impacts of products and processes throughout their entire life cycles. Has help the Environmental aspects in: Reducing risk; Reduce costs; Reduce time-to-profit; Eliminate the use of banned materials; Enhance Disassembly/Reuse/Recycle
Gain competitive advantage.
Efficiency Index or Ei, is an internal metric from the Pharmaceutical Sector within J&J, which is a way to measure how effectively we convert raw materials into finished goods. The ultimate goal is an Ei of 100%, which means that we are using all of our raw materials in our manufacturing processes with no waste. The closer we get to Ei 100 the better we are doing. Improving this metric we were able to reduce the generatioon of hazardous waste associated to cleaning process, such as Alcohol and rags, among others.
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An increase in volume of operation have impacted the generation of hazardous waste at the site. Particularly the integration of Quality Assurance testing from other pharmaceutical facilities of PR into the Janssen Ortho LLC operation have impacted this measurement. This testings required usage of solvents that shall be disposed of as hazardous waste. Opportunities for improvement will be evaluated during this year.
Normalization factor is based on 4755 MM Units produced in 2003 vs 5111 MM units produced in 2004. |
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OMB No. 2010-0032
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SECTION E: SELF-CERTIFICATION OF CONTINUED PROGRAM PARTICIPATION FOR ANNUAL PERFORMANCE REPORT
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The U.S. Environmental Protection Agency is not yet in a position to accept electronic signatures and therefore requests a faxed, signed copy of the Section E page. Please complete Section E online, then print Section E using the link on the Overview page. Section E should be signed by the senior manager of your facility and faxed it to the Performance Track Information Center at (617) 354-0463.
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On behalf of Janssen Ortho LLC, I certify that:
- I have read and agree to the terms and conditions as specified in the National Enviromental Performance Track Program Guide. This facility, to the best of my knowledge, continues to meet all program criteria;
- I have personally examined and am familiar with the information contained in this Annual Performance Report. The information contained in this report is, to the best of my knowledge and based on reasonable inquiry, true, accurate, and complete;
- My facility has an environmental management system (EMS), as defined in the Performance Track EMS criteria, including systems to maintain compliance with all applicable federal, state, tribal, and local environmental requirements, in place at the facility, and the EMS will be maintained for the duration of the facility's participation in the program;
- My facility has conducted an objective assessment of its compliance with all applicable federal, state, tribal, and local environmental requirements; and the facility has corrected all identified instances of potential or actual noncompliance; and
- Based on the foregoing compliance assessments and subsequent corrective actions (if any were necessary), my facility is, to the best of my knowledge and based on reasonable inquiry, currently in compliance with applicable federal, state, tribal, and local environmental requirements.
I agree that EPA's decision whether to accept participants into or remove them from the National Environment Performance Track is wholly discretionary, and I waive any right that may exist under any law to challenge EPA's acceptance or removal decision. I am the senior manager with responsibility for the facility and am fully authorized to execute this statement on behalf of the corporation or other legal entity whose facility is part of the National Environmental Performance Track program.
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| ______________________________________________________ |
| Mr. Ivan Cartagena |
| General Manager |
| 787-272-7600 |
| ICartage@janpr.jnj.com |
| Janssen Ortho LLC |
| Road 933 KM 0.1 Mamey Ward Gurabo, PR 00778-9629 |
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| A020020 |