Performance Track Logo
OMB No. 2010-0032
Expiration Date 01/31/2010
2007 Performance Track Annual Performance Report

















Fenwal Blood Technologies, Maricao PR
A020056
Year 2 Annual Performance Report
Member Since 2003 (2nd Member Term)



























SECTION A: GENERAL FACILITY INFORMATION


Fenwal Blood Technologies, Maricao PR

 
Fenwal International Inc.

  Mr. Noel Toledo
  EHS Manager
  (787) 838-3000-Ext 6505
  (787) 838-2110
  noel.toledo.mercado@fenwalinc.com


Road 357 km 0.8
Maricao
PR
00606


PO Box 832
Maricao
PR
00606


http://www.fenwalinc.com

500-1,000

325412


Our facility manufacture Blood Pack Units for blood collection. It are manufactured from vynil material and is distributed all around the world.

Our facility is located in Maricao, Puerto Rico. We are occupying four building leased to Puerto Rico Industrial Company. Two of these buildings are for manufcaturing operations, which are a total of 106,155 square feet. Our operations include the preparation of the raw material cutting it to size for the sealing operation using RF equipments. And the extrusion of the PVC tubing that are going to be included in the blood pack unit to collect and dispense the blood. The second part of the assembly operations includes the addition of anti-coagulant solution, sterilization and packing process. It completes the assembly process, allowing our product to be ready for the customer.
The remain two buildings we have a space of 33,560 square feet for storage of raw material, finish good and MRO material for the operation.

No



SECTION B: ENVIRONMENTAL MANAGEMENT SYSTEM


Yes


February 2007
ISO 14001 Standards
Specify:
Name: Mr. Steve Ellis
Title: ERM/CVS Lead Assessor
Organization: ERM/CVS
Policy, Planning, Implementation, Checking, Management
Entire Facility



Yes

October 2007
Policy, Planning, Management
Entire Facility



Yes

October 2007
Clean Air Act (CAA)
Clean Water Act (CWA)
National Pollutant Discharge Elimination System (NPDES)
Resource Conservation and Recovery Act (RCRA)





Yes


Yes

Mr.  Luis M. Carrillo
  General Manager


December 2006



SECTION C: ENVIRONMENTAL PERFORMANCE RESULTS



Goal 1: Fenwal Blood Technologies, Maricao PR's first goal is to reduce the facility's total water use.
-Waterless hand sanitizer were completely implemented in all the gowning areas. We are encouraging our employees to use this process as the primary hand cleaning process in our dressing and GMP code and regulation.
- Correction of water loss through pipes from the main line.
- Were substitute seven (7) regular urinals for waterless units to reduce the water usage for this activity.
- Correction of water loss through pipes from the fire system.
- Use of waterless hand sanitazer

We are monitoring the monthly water usage from our city water and the well water. This information is part of our monthly metrics that are discussed within the staff. The normalization of this total with the Single Pack Unit provides the final number against our goal.

 
 
2005
2006
2007
2008
Actual Quantity (per year) 27,555,170 21,156,464 22,135,339 n/a Gallons

Normalizing Factor 1.0 0.92 0.97
Normalized Quantity 27,555,170 22,996,156.52 22,819,937.11 23,400,000 Gallons
The normalizing factor is based total production activity of single pack unit produced in our manufacturing area during the year.





Goal 2: Fenwal Blood Technologies, Maricao PR's second goal is to reduce the generation of, and improve the management of, the facility's non-hazardous waste.
- We are reinforcing the importance for recycling, re-using, repairing through the introduction of additional points of collections of the recycle material through out the facility. Supervisors are engage in the program and are subject to inspections to assured they ahve the corresponding collecting container in use.
- We are increasing the volume of material recycled, wet PVC, through the addition of a shredder machine. This equipment allowed to our recycling team to process more quickest the collected material and for the recycler to have a better way to handle it. We have eliminated the need to send to the landfill this material, in a 100%.
-We have identified a recycling market for finished good plastic materials. Before, this material was disposed in the landfill.

- Part of the waste reduction was due to product quality improvement.

We provide employee awareness related to recycling material
and waste generated from our operations, and emphasize to re-use any material for other activities. This materials includes cardboard and polyethilene, that some of this material have been dumped into the non-hazardous waste compactor for disposal in the landfill.

In addition we have reduced waste to landfill by identifying a recycling broker that is receiving our stainless steel needle contaminated with plastic covers.

-Material recycled are weight before send it to the recycling company on monthly basis and records are maintained in an excel spreadsheet.
- Cardboards are compacted in bundle of 600 lbs, this is an standard size using a vertical compactor.
- Same process is used to manage the recycled plastic and poliethylene material.
- Shredded material are manage in bags that weight 35 lbs, that is managed by the recycling personell, collected in a trailer of 40 feet and mainatained in our facility untilit is fill-up.
-All data collected is audited by our facility and the recycler company that revise the documents and the weight of the bags randomly.
-Dry PVC material are weighted using the in-house sclae in the warehouse area. This equipment is also used to weight our finish product for delivery purposes and a claibration program does exist to comply with standards.
-Data is communicated to the staff on monthly basis.
- Domestic waste is contained in two 40 yds containers that are moved from our facility on bi-monthly and some times every three month, depend upon our activity. Because we are collecting the domestic waste in these two containers and the service is on-call, we maintained our service tickets and called them to have the information of the weight related to this container. This information is maintained in our internal data base in the excell spreadsheet.

2005
2006
2007
2008
Landfill 248 159 124 Tons
Reused/recycled off-site 1,100 675 857 Tons

Total Non Hazardous Waste 1,348.00 834.00 981.00 n/a Tons


Normalizing Factor 1.0 0.92 0.97
Total Non Hazardous Waste 1,348.00 906.52 1,011.34 1,140.00 Tons

The normalizing factor is based total production activity of single pack unit produced in our manufacturing area during the year.





Goal 3: Fenwal Blood Technologies, Maricao PR's third goal is to reduce the facility's total (non-transportation) energy use.
-New technology and process has been identified and bought a power generator and air compresssor tyo increase energy efficiency.
-Both of this new equipments has been received but equipment certification was not completed by end of year 2007 as it was scheduled.
- Activity identified as the major contributor on energy use was the A/C units. For it evaluated and change the room temperature to estabilized it and assure confort and compliance with our process resulting on reduction of energy consumption.
- Were also identified equipment that were maintained running 24 hrs where the area do not required them, and was establish a timer to turn them off.
- Office light switchs were change for photo cells to assured that are off whenever no one is in the room.
- We have in use 3 boilers that consume diesel to produce water vapor. A new technoligy consisting in the use of magnets to improve the fuel efficiencty was incorporated in our system reducing the diesel consumption in 10% from previous year.
- Has been incorporate solar water heaters to avoid the usage of power to maintain hot water in the cleaning room to clean the hands process prior to enter to the clean room.
- We are validating the usage of Cal-Stat, a germicide, to reduce the dependence from the water to clean the hands prior to enter to the clean room.

Note: 2005 and 2006 data were revised on September 17, 2007 to correctly report electricity use. Previously 16.21 Mwh and 14.55 Mwh were reported instead of 16,212,340 Kwh and 14,551,020 Kwh. 2005 data was also previously updated to include diesel fuel and propane consumption and to remove fuel oil, which should have been reported as diesel.

-Data for the electricity from utility are collected using the electricity bill.
-Diesel consumption data is maintained whenever we receive a truck to fill our tanks. It is also used for the air emmisssion records and report to local agency, Environmental Quality Board.
-Propane gas data is collected in the same way as the diesel, whenever a delivery occurred.


16,212,340 14,551,020 15,608,340 Kwh
0 0 Kwh
55,316.50 49,648.08 53,255.66 MMBtus

Puerto Rico


EPA will be determining the greenhouse gases associated with the generation of the steam that you purchase. We will be contacting you for additional information regarding the source of the steam generated.
55,316.50 49,648.08 53,255.66

42,947.3 39,914.9 39,154 MMBtus
320.544 285.768 310.390 MMBtus
43,267.84 40,200.67 39,464.39

553.17 496.48 532.56 n/a
98,031.18 89,352.27 92,187.49 n/a
98,584.34 89,848.75 92,720.05 n/a
16,227.77 14,661.74 15,467.86 n/a
0
16,227.77 14,661.74 15,467.86 n/a


1.0 0.92 0.97
98,584.34 97,661.68 95,587.68 95,693.22 MMBtus
16,227.77 15,936.67 15,946.25 15,539.73 MTCO2E

The normalizing factor is based total production activity of single pack unit produced in our manufacturing area during the year.






In the table below, please provide a narrative summary of progress made toward EMS objectives and targets other than those reported as Environmental Performance Goals. You may limit the summary to environmental aspects that are significant and towards which progress has been made during the reporting year.

Do you have additional environmental aspects to report?   Yes

(e.g., quantitative or qualitative improvements, activities conducted)
Noise exposition Audit and monitoring was performed in all areas that are within the hearing conservation program. Have been demonstrate that noise decibels have not been increased, and we still in the need to continue with this program.
Non-Ionizing radiation exposition Monitoring for the exposition of non-ionizing radiation was conducted on Novemeber 2007. This monitoring has demonstrate that all equipments are performing under the exposure limits according to the regulation.(IEEE C95.1-1991/ANSI C95.1-1992 limits Head and Groin area readings multiplied by the duty factor to a maximum of : E-Field = 1.22 mW/cm2 H-Field = 13 mW/ cm2 Induced Current = 200mA )






SECTION D: PUBLIC OUTREACH AND PERFORMANCE REPORTING


We have sponsored the effort from public school in their reforestation projects.
-Actively participate with local goverment activities and meeting for the emergency response plan.
-Support local emergency agencies providing absorbent material and support in the process to dispose some of the absorbent material used to collect used oil.


- We maintain close relation with the Municipal recycling department and help them through the collection of material to improve their performance, establishing our committment in the environment concern.
- Contacting the team leader for the school or the community committe and be part of the solution, providing knowledge, material and human resources from our labor force.

-We have environmental fair in our facility and invite the community to receive information from them.


Open House, Meetings, Community Advisory Panel, Building Lobby, Environmental Fairs








OMB No. 2010-0032

SECTION E: SELF-CERTIFICATION OF CONTINUED PROGRAM PARTICIPATION FOR ANNUAL PERFORMANCE REPORT


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.

On behalf of Fenwal Blood Technologies, Maricao PR, 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.

______________________________________________________
Mr. Luis M Carrillo
Plant Manager
Fenwal Blood Technologies, Maricao PR
Road 357 km 0.8
Maricao, PR 00606
PO Box 832
Road
Maricao , PR 00606
A020056