ANNUAL ENVIRONMENTAL REPORT 2008
Pharmaceuticals Ireland
TEVA PHARMACEUTICALS IRELAND UNIT 301
INDUSTRIAL ESTATE WATERFORD
IPC LICENCE REG. P0099-01
Page 2 of 54
TABLE OF CONTENTS
1. Introduction …............................................................................................................. 3 1.1 Executive Summary ………………………………………………………………………..3
1.2 Purpose ……………………………………………………………………………….. 3
2. Background …………………………………………………………………………. 4 2.1 The Company ………………………………………………………………………... 4 2.2 Economic Contribution ……………………………………………………………….. 4 2.3 Local Environmental Conditions ………………………………………………….. …... 4 2.4 Financial Allocation for Environment ……………………………………………… 4
3. Environmental Health & Safety Policy ………………………………………….. 5
4. Environmental Management Organization Chart ………………………………….. 6
5. Emissions to Sewer - (ES301-1) …………………………………………………... 7 5.1 Trend Analysis ………………………………………………………………………… 7 5.2 Monthly Average pH ……………………………………………………………….... 8 5.3 Monthly Average Temperature ………………………………………………………... 8 5.4 Average Flow Rate ………………………………………………………………… 9 5.5 Monthly Discharge Volumes ………………………………………………………... 9 5.6 Screening for Organics ……………………………………………………………….... 10 5.7 Details of Non-Conformances ………………………………………………………... 11 5.8 Phenol Trend 2005- 2008 ………………………………………………………………... 12 5.9 Summary of Non-Conformances 2006-2008 …………………………………………... 13
6. Surface Water Emissions – (SW301) …………………………………………… 14 6.1 Monthly Average pH ………………………………………………………………… 14 6.2 Monthly Average TOC ………………………………………………………………… 14 6.3 Monthly Conductivity ……………………………………………………………….... 15 6.4 Details of Non-Conformances ……………………………………………………….. 15
7. Emissions to Atmosphere: …………………….……………………………………... 16 7.1 Mass Emissions for VOC’s and Particulates 2006 - 2008 ……………………..………. 16 7.2 Air Emission Summary …………………………………………………...…………… 17
8. Hazardous & Non-Hazardous Waste Management …………………………… 18 8.1 Hazardous Waste Data Table 2008: ……………………………………………….. 18 8.2 Non-hazardous Data Table 2008: ……………………………………………….. 19 8.3 Hazardous Waste Summary 2006-2008: ……………………………………………….. 20 8.4 Non-Hazardous Waste Summary – 2006-2008: ………………………………………. 21
9. Energy & Water Consumption …………………………………………………… 22 9.1 Energy Consumption: 2006 – 2008 ……………………………………………….. 22 9.2 Water Consumption: 2006 – 2008 ……………………………………………….. 23
10. Solvent Usage & Pollutant Release and Transfer Register ………………………… 24 10.1 Summary Information: Solvent Usage 1998 – 2008……………………………………… 24 10.2 Pollutant Release and Transfer Register 2008…………………………………………….. 24
11. Noise …………………………………………………………………………………… 25 11.1 Findings of Noise Survey Report 2008……………………………………………..……… 25 11.2 Noise Survey Report ………………………………………………………………… 25
12. Environmental Complaints …………………………………………………………… 26 12.1 Complaint Details ………………………………………………………………… 26
13. Management of the Activity …………………………………………………………… 26 13.1 Teva’s Future Plans for the Management of the Activity ……………………………… 26 13.2 Environmental Management Programme ……………………………………………….. 26
APPENDIX 1 Pollution Emission Register 2008 APPENDIX 2 Noise Survey Report 2008
Page 3 of 54
1. INTRODUCTION
1.1 Executive Summary
The AER for 2008 has remained consistent with the terms of the licence and is in line with previous years.
There are however some notable exceptions. In 2009, Teva Pharmaceuticals Ireland hopes to gain
accreditation to both OHSAS 18001 and ISO 14001 from BSI (British Standards Institute). Hence, these
management systems will become the cornerstone of developing the environmental objectives and targets
(ISO 14001). This report integrates the objectives and targets from this management system with the current
objectives and targets from 2007. The previous objectives and targets are complete or as already mentioned
have been amalgamated with ISO 14001.
The majority of metrics show that Teva is in line with its IPPC licence and has applied BAT and
improvement systems to its plant.
Furthermore, the company expects to have certain areas of its IPPC licence revisited by the EPA in 2009.
The licence is a number of years old, and hence certain conditions contained within it may no longer be be
relevant to current site activities.
The AER/PRTR returns template that the EPA sent out still has Ivax Pharmaceuticals Ireland as the name of
the company. This will be adjusted for next year.
1.2 Purpose
This Annual Environmental Report is submitted in fulfilment of condition 2.9.2 of the IPC Licence (Licence
Register No.P0099-01) issued on the 30th May 1997.
This format, by authority of the agency, presents summary information (in line with the Guidance notes for
the Annual Environmental reporting), for the year 2008.
Also in this AER is a draft environmental management programme for 2008 onwards that will replace the
previous programme that covered the period 2003 – 2007.
Page 4 of 54
2. BACKGROUND
2.1 The Company
Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company specializing in the development,
production and marketing of generic and proprietary branded pharmaceuticals as well as active
pharmaceutical ingredients.
Teva Pharmaceuticals Ireland consists of Aerosol manufacturing plants producing asthmatic inhalers and an
Oral Solid Dose manufacturing and packaging plant producing generic prescription tablets/capsules.
Extensive quality control and assurance departments support the manufacturing operations. TEVA also have
extensive R&D Departments, responsible for the design, development and introduction of their product
range.
The aerosol plants (units 14-15 and 27-35), are not IPC licensable activities. The tablet manufacturing and
packaging plant (unit 301) is licensed under section 12.2.2 of the first schedule of the EPA Act 1992.
The company has operated an Environmental Management System since 1994 when a preliminary
environmental review was performed. Teva maintains a full time EHS department, consisting of an EHS
Manager, an EHS Officer, an H&S Specialist, an Occupational Health Nurse and a Process Safety Specialist.
2.2 Economic Contribution
The company currently employs a total of 828 personnel in Waterford of which approximately 491
employees are involved in the Unit 301 Solid Dose plant operation.
2.3 Local Environmental Conditions
The location of Teva Pharmaceuticals Ireland on the IDA Industrial Park, Waterford, could be described as
suburban, bordering on rural. The site is approximately 2 kilometres from the city. The surrounding land is
mainly used for agriculture particularly to the North and North West of the estate, however due to economic
growth in the region the rural surroundings are becoming more developed with commercial and industrial
units under construction. The nearest features of interest within a 5 km. radius are St. Otteran’s cemetery, the
River Suir, and the dispersed prehistoric and early Christian monuments in the surrounding area.
2.4 Financial Allocation for Environment The major capital items to support the IPC programme have already been committed. Environmental, health
and safety is a discrete cost centre in its own right within Teva
Page 5 of 54
3. ENVIRONMENTAL HEALTH AND SAFETY POLICY
Page 6 of 54
4. Environmental Management Organisation Chart
TEVA Ireland’s General Manager
Inhalations Plant manager
Head of Materials
Head of Quality
Solid Dose Plant Manager
Head of Finance
Head of Human Resources
Director of R&D Waterford
EHS Manager
Occupational Health Nurse
Process Safety Specialist
EHS Officer
H&S Specialist
Head of Human Resources
EHS Manager
Occupational Health Nurse
Process Safety Specialist
EHS Officer
H&S Specialist
Page 7 of 54
5. Emissions to Sewer - (ES301-1)
5.1 Emissions to Sewer - Trend Analysis and Summary Data of Mass Emissions
Mass Emissions - Trend Analysis (a)
0
2000
4000
6000
8000
10000
12000
14000
16000
18000
20000
Parameter
Mass Emission (kgs)
2006 4088 166 156 1488 371 153
2007 3315 196 95 1204 280 95
2008 4913 306 309 1558 499 131
Limit 18250 18250 18250 9125 3650 1825
COD Chlorides Sulphates BOD Suspended Solids Oils/Fats/Greases
Mass Emissions - Trend Analysis (b)
0.00
20.00
40.00
60.00
80.00
100.00
120.00
140.00
160.00
180.00
200.00
Parameter
Mass Emission (kgs)
2006 0.96 37.25 0.14 17.80 1.78
2007 1.10 34.97 0.00 2.63 0.93
2008 52.90 68.28 6.75 14.98 1.49
Limit 182.5 91.25 91.25 36.5 1.825
Nitrates Phosphorus Heavy Metals Ammonia Phenols
Page 8 of 54
5.2 Monthly Average pH:
Emissions to Sewer - Average pH
4.00
5.00
6.00
7.00
8.00
9.00
10.00
Month
pH Scale
2006 6.94 7.01 7.01 6.95 6.86 7.21 7.46 7.32 7.16 7.37 7.18 6.74
2007 7.40 6.42 6.98 6.70 6.84 6.94 6.81 6.87 7.01 7.24 6.93 6.71
2008 6.85 6.70 7.04 6.83 6.82 6.68 7.30 6.63 7.04 7.53 7.12 7.15
L Limit 6 6 6 6 6 6 6 6 6 6 6 6
U Limit 9 9 9 9 9 9 9 9 9 9 9 9
1 2 3 4 5 6 7 8 9 10 11 12
UPPER LIMIT
LOWER LIMIT
5.3 Average Monthly Temperature:
Emissions to Sewer - Average Temperature
0
5
10
15
20
25
30
35
40
45
Month
Temperature (oC)
2006 9.9 10 11.25 14.4 16.7 19.8 20.2 17.7 17.97 15.5 11.54 8.8
2007 9.13 8.98 9.7 12.05 14.03 16.78 16.16 15.74 15.29 13.75 10.74 9.2
2008 9.02 8.76 8.71 10.25 13.68 15.63 17.43 16.48 15.99 14.08 11.18 9.42
Limit 42 42 42 42 42 42 42 42 42 42 42 42
1 2 3 4 5 6 7 8 9 10 11 12
EMISSION LIMIT
Page 9 of 54
5.4 Average Monthly Flow Rate:
Emissions to Sewer - Average Flowrate
0
1
2
3
4
5
6
7
8
m3/h
2006 0.541 1.23 1.09 0.74 0.53 0.83 0.74 1.07 0.75 0.79 0.78 0.79
2007 0.6135 1.0367 0.8418 1.1663 2.1664 1.3679 0.79 1.1881 1.3167 0.7336 0.8555 0.6583
2008 0.96 0.76 0.95 0.82 0.81 0.99 0.92 0.9 1.03 1.21 0.98 1.1
m3/hr 7 7 7 7 7 7 7 7 7 7 7 7
Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec
5.5 Monthly Discharge Volumes:
Emissions to Sewer - Discharge Volumes
0
100
200
300
400
500
600
700
800
900
1000
Month
Discharge Volumes (m
3)
Discharge Volumes 2006 393.26 820.33 628.85 521.73 386.44 586.91 527.23 781.12 533.28 541.76 551.11 576.01
Discharge Volumes 2007 447 449 530 248 98 231 569 566 549 514 604 454
Discharge Volumes 2008 682 543 658 516 578 700 649 655 784 909 692 773
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
MEMISSION LIMIT
Page 10 of 54
5.5 Screening for Organics
TEVA analyses the effluent from ES301-1 for the most commonly used solvents, namely Methylene
Chloride, Methanol, Acetonitrile, Chloroform and Isopropanol.
5.6.1 Summary Information of Screening for Organics 2008
5.6.2 Summary Information of Screening for Organics 2007
5.6.3 Summary Information of Screening for Organics 2006
Date Methylene
Chloride Methanol Isopropanol Acetonitrile Chlorofor
m
17/04/08 <1.0 ppm 11.2 ppm <1.0 ppm <1.0 ppm <1.0 ppm
11/06/08 <1.0 ppm 8.55 ppm <1.0 ppm <1.0 ppm <1.0 ppm
19/11/08 <1.0 ppm <1.0 ppm <1.0 ppm 2.4 ppm <1.0 ppm
17/12/08 <1.0 ppm <1.0 ppm <1.0 ppm <1.0 ppm <1.0 ppm
Date Methylene
Chloride Methanol Isopropanol Acetonitrile Chlorofor
m
28/03/07 <0.1 ppm <0.1 ppm <0.1 ppm <0.1 ppm <0.1 ppm
27/06/07 <0.1 ppm <0.1 ppm <0.1 ppm <0.1 ppm <0.1 ppm
12/09/07 <0.1 ppm <0.1 ppm <0.1 ppm <0.1 ppm <0.1 ppm
19/12/07 <0.1 ppm 10.9 ppm 2 ppm <0.1 ppm <0.1 ppm
Date Methylene
Chloride Methanol Isopropanol Acetonitrile Chloroform
23/03/’06 <0.1 ppm <0.1 ppm <0.1 ppm <0.1 ppm <0.1 ppm
23/05/’06 <1.0 ppm <1.0 ppm <1.0 ppm <1.0 ppm <1.0 ppm
16/08/’06 <1.0 ppm <1.0 ppm <1.0 ppm <1.0 ppm <1.0 ppm
10/11/’06 <1.0 ppm <1.0 ppm <1.0 ppm <1.0 ppm <1.0 ppm
Page 11 of 54
5.7 Details of Non-Conformances – Effluent 2008
Date Non-Compliance Cause Corrective Action
July
August
Suspended Solids
concentration exceeded
emission limit value.
Adverse weather
conditions caused the sump
in treatment plant bund to
fill with rain water which
agitated sludge on the base
of the sump. When the
level of water in the sump
reached the “high” level
the contents were
automatically pumped
through the system causing
elevated suspended solids
concentrations in the waste
water.
Horizon Environmental
called to site (08/09/’08)
to pump out sludge from
the sump and any other
areas where sludge may
have settled in the
system. The frequency of
sludge removal will be
increased to ensure the
same conditions will not
occur in the future
December Ammonia concentration in
the effluent exceeds the
licence ELV following
monthly analysis.
The exceedence in
Ammonia may be as a
result of the use of a
chemical that is used in the
boilers. This chemical,
Alchem 1102 is used in
preventative maintenance
of the boilers and was used
around the date that
TelLabs took the sample
(17th December 2008- 20
th
December 2008). This is
we feel the cause of the
high ammonia reading.
Discussion with
engineering concerning
Alchem 1102 to highlight
the issue of an amine
group attached to the
chemical and
consequently its relation
to the IPPC licence.
April
May
June
July
August
October
November
Phenol concentration in the
effluent exceeds the
licence ELV following
monthly analysis.
Investigation into the level
of phenol in the waste
water has shown that raw
materials used in the
company are phenolic in
origin themselves.
It can be seen from the
phenol trend graph ’05-
’08, 5.8 below, that there
has been a significant
reduction in phenol
emitted over this period.
December Total Phosphorus
The total Phosphorus
investigation has proven to
be inconclusive. Prior to
the Christmas period, there
was a large scale clean
down. This would have
meant that some of the
cleaning agents used may
have had phosphorus or a
derivative of it. It is only
presumption to suggest that
perhaps there was over
zealous amount of cleaning
agent used.
Further discussion
surrounding Phosphorus
to continue within the
company to understand
better where this
exceedence originated
Page 12 of 54
5.8 Phenol Trend 2005- 2008
Phenol Trend 2005 - 2008
0
0.5
1
1.5
2
2.5
Jan '05Mar
May
July
SeptNov
Jan '06
Mar
May
July
SeptNov
Jan '07
Mar
May
July
SeptNov
Jan '08Mar
May
July
SeptNov
Phenol (mg/l)
Phenol Limit Linear (Phenol)
Page 13 of 54
5.9 Summary of Non-Conformances Summary 2006-2008
Summary of Non - Conformances Summary 2006-2008
0
5
10
15
20
25
Emmision
No. of Non-Conformances
2006
2007
2008
2006 4 11 0 0 0 1 0 0 16
2007 0 8 0 2 0 1 0 0 11
2008 0 18 0 0 0 1 2 1 22
Discharge
volumePhenol pH COD BOD Ammonia
Suspended
solidsPhosphorus Total
Summary of improvements in control:
• The number of “discharge volume” non-conformances has decreased significantly due to;
o Increased control on the diversion system on the outflow. This had been identified
previously as an issue that needed to be rectified.
o Increased control in the manufacturing wash down cycle that prevented previous
incidents where excessive amounts of wash water generated led planned releases, above
the licensed limit, in order to prevent the waste water treatment plant overflowing.
• Modifications to the diversion control system also led to the elimination of non-conformances
whereby waste water could be released to the environment when out of specification.
• Phenol emission rates have flattened out from the early reductions in January 2005 to the
present levels which have become the norm. Waterford County Council have agreed to an
emission limit increase on the trade effluent licence from 0.1 mg/l to 0.5 mg/l which will
eliminate the major issue with phenol, subject to approval by the Agency.
Page 14 of 54
6. Surface Water Emissions – (SW301)
6.1 Surface Water – Average Monthly pH:
Surface Water - Average pH
4
5
6
7
8
9
10
Month
pH Scale
2006 7.774 7.859 7.459 7.414 7.707 7.825 7.358 7.72 7.31 7.717 7.77 7.88
2007 7.821 7.587 7.674 7.074 7.292 7.51 7.488 7.699 7.741 7.548 7.266 7.575
2008 7.792 7.408 7.778 7.129 7.704 7.979 7.552 7.345 7.783 8 7.87 7.731
Lower Limit 6 6 6 6 6 6 6 6 6 6 6 6
Upper Limit 9 9 9 9 9 9 9 9 9 9 9 9
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
6.2 Surface Water - Monthly Average Total Organic Carbon:
Surface Water - Total Organic Carbon
0
10
20
30
40
50
60
70
Month
TOC (PPM)
2006 3.2 2.06 4.43 2.45 4.67 4.9 4.22 6.52 6.23 5.48 4.21 3.97
2007 5.76 5.16 4.66 5.21 9.09 5.24 6.76 2.63 5.86 5.1 5.6 5.6
2008 9.72 9.88 9.2 10.21 9.33 12.39 10.52 8.71 4.53 9.34 10.18 21.38
Emission Limit 60 60 60 60 60 60 60 60 60 60 60 60
1 2 3 4 5 6 7 8 9 10 11 12
Page 15 of 54
6.3 Surface Water - Monthly Conductivity:
Surface Water - Conductivity
0
0.1
0.2
0.3
0.4
0.5
0.6
Month
Conductivity (ms)
2006 0.425 0.443 0.497 0.395 0.158 0.259 0.284 0.352 0.448 0.464 0.482 0.457
2007 0.401 0.489 0.399 0.422 0.418 0.477 0.484 0.491 0.389 0.389 0.357 0.329
2008 0.399 0.412 0.443 0.45 0.42 0.406 0.432 0.405 0.435 0.467 0.493 0.457
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
6.4 Summary of Surface Water Non-Compliances, SW301
Date Non-Compliance Cause Corrective Action
N/A N/A N/A N/A
There was no surface water non-compliances recorded during 2008.
Page 16 of 54
7 Emissions to Atmosphere: 2006 - 2008
7.1 Mass Emissions for VOC’s and Particulates 2005 - 2007
Note: Below graphs also shows 2005 emissions for both Methylene Chloride and Isopropanol but is not
shown above in the three year table
7.1.1 Methylene Chloride ’05-’07.
Methylene Chloride
0
0.005
0.01
0.015
0.02
0.025
0.03
0.035
0.04
0.045
0.05
kgs
Methylene Chloride 0.017 0.047 0.035
2005 2006 2007
7.1.2 Isopropanol ’05-’07.
Isopropanol
0
0.0005
0.001
0.0015
0.002
0.0025
0.003
kgs
Isopropanol 0.0025 0.0016 0.0005
2005 2006 2007
Emission
Point
Process Parameter 2006 - Mass
Emissions (Kg)
2007 - Mass
Emissions (Kg)
2008 - Mass
Emissions (Kg)
301/1.16 TU6 Methylene Chloride .047 kg .035 kg N/A
301/1.16 TU6 Isopropanol .0016 kg .0005 kg N/A
301/1.16 TU6 Ethanol N/A N/A 0.117 kg
301/2.3 ANDA Particulates .0000014 kg .0000006 kg N//A
Page 17 of 54
7.1.3 Ethanol ’06 –‘08
Ethanol
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
Kg
s
Ethanol 0 0 0.117
2006 2007 2008
7.1 Air Emissions Summary:
• The above data shows information from the 2007 AER as well as information collected
during 2008 for one solvent, ethanol.
• During an inspection by Tony Dolan and Pamela McDonnell of the Environmental
Protection Agency, the difficulty in sampling of the solvents used at Teva Pharmaceuticals
Ireland was discussed.
• In 2008, Ethanol was the only solvent sampled for at emission point 301/1.16. This was due
to a variety of reasons, including the fact that emission points were not in use during the
year and difficulties in arranging the sampling of batch processes.
• As a result of this conversation with the before mentioned EPA inspectors, the company
hopes to apply to the EPA to discontinue the monitoring of air emissions as it feels they no
longer represent a licensable activity in 2009.
8 Hazardous & Non-Hazardous Waste Management
8.1 Hazardous Waste Data Table 2008:
European Waste
Catalogue Code
Hazardous
(Yes/No)
Description of
Waste
Quantity
(t/year)
Disposal/ Recovery
Code
Location of
Disposal/
Recovery
Name of Waste
Disposal Recovery
Contractor
Licence /
Permit
Reference
07 05 03* Yes Chlorinated Solvent 7.093
D10 Incineration on
land
(c) Off-site
Abroad
DEE Environmental
Services c/o Veolia AG8233
07 05 04* Yes
Non Chlorinated
Solvent 44.72
D10 Incineration on
land
(c) Off-site
Abroad
DEE Environmental
Sevices c/o Veolia AG8233
07 05 99 Yes
Tablet/Powder/Filter
waste 120.53
D10 Incineration on
land
(c) Off-site
Abroad
DEE Environmental
Services c/o SAVA A 51G00508
16 05 07* Yes
Residual Laboratory
Waste 0.249
D10 Incineration on
land
(c) Off-site
Abroad
DEE Environmental
Services c/o SAVA A 51G00508
16 05 08* Yes
Residual Laboratory
Waste 0.778
D10 Incineration on
land
(c) Off-site
Abroad
DEE Environmental
Services c/o SAVA A 51G00508
15 01 10 Yes Drums 1.582
D9 Physico Chemical
Treatment
Off Site, Eire
DEE
Environmental
Services c/o AVR
Safeway, Corrin,
Fermoy
50-1
15 02 02* Yes Filters 5.644
D10 Incineration on
land
(c) Off-site
Abroad
DEE Environmental
Services c/o SAVA A 51G00508
18 01 03 Yes Clinical Waste 1.4448
D9 Physico Chemical
Treatment
Off Site, Eire
DEE
Environmental
Services C/o
Ecosafe Systems
54-2
Page 19 of 54
8.2 Non- Hazardous Waste Data Table 2008:
European Waste
Catalogue Code
Hazardous
(Yes/No)
Description of
Waste
Quantity
(t/year)
Disposal/ Recovery
Code
Location of
Disposal/
Recovery
Name of Waste
Disposal Recovery
Contractor
Licence /
Permit
Reference
20 03 01 No
General /
Canteen Waste 274.56
D1 Deposit on, in or
under land.
(b) Off-site
Ireland
Baleally Landfill,
Lusk, Co. Dublin. -
KTK Landfill Ltd.,
Kilkullen, Co.
Kildare.
WL Ref: 9-2
& WL Ref:
81-2
15 01 01 No Cardboard
284.89
R5
Recycling/reclamation of
other inorganic materials
(b) Off-site
Ireland Smurfit Recycling WP021
15 01 02 No Plastic (Bales) 106.49
R5
Recycling/reclamation of
other inorganic materials
(c) Off-site
Abroad Dilloan Recycling BLT658585
20 01 08 No Compost 16.03
R10 Land treatment
resulting in benefit to
agriculture or ecological
improvement
(b) Off-site
Ireland
Veolia
Environmental
Services. WR/02/00
20 01 01 No
Confidential
Paper
101.46
R5
Recycling/reclamation of
other inorganic materials
(b) Off-site
Ireland Smurfit Recycling WP021
15 01 03 No Timber Pallets 29.32
R7 Recovery of
components used for
pollution abatement
(b) Off-site
Ireland
Veolia
Environmental
Services. WR/02/00
15 01 07 No Glass 10.56
R5
Recycling/reclamation of
other inorganic materials
(b) Off-site
Ireland
SFL Calan, Co.
Kilkenny WR/02/00
20 01 40 No Scrap Metal 30.54
R5
Recycling/reclamation of
other inorganic materials
(b) Off-site
Ireland
Midland Scrap
Metal Recycling WMB005
8.3 Hazardous Waste Summary 2006-2008:
Hazardous Waste Summary 2006-2008
0
50
100
150
200
250
Tonnes
2006 160.28 28.1 2.94 1.2 1.208 0 9 0 0 0 202.728
2007 143.18 20.42 18.81 0.61 3.981 0.028 0 0.11 1.598 1.5522 190.2892
2008 120.53 44.72 7.093 1.027 5.644 0 0 0 1.582 1.4448 182.0408
Tablet &
Powder
Non-
Chlorinated
Solvent
Chlorinated
Solvent
Residual Lab.
ChemicalsFilters Glass
Waste
Washings
Fluorescent
TubesDrums Clinical waste TOTALS
The graph below normalizes the amount of hazardous waste generated per unit of production ‘06-
08’
Hazardous Waste / Unit Produced
0
10
20
30
40
50
60
70
80
mg/unit
Haz Waste per Unit 67.5 67.9 48.9
2006 2007 2008
Page 21 of 54
8.4 Non-Hazardous Waste Summary – 2006-2008:
Non-hazardous Waste Summary 2006 - 2008
0
100
200
300
400
500
600
700
800
900
Tonnes
Landfilled 183.84 197.3 274.56
Recycled 248.05 306.88 579.29
Total 431.89 504.18 853.85
2006 2007 2008
The graph below normalizes the amount of non-hazardous waste generated per unit of production
’06-‘08.
Non Hazardous Waste / Unit Produced
0
50
100
150
200
250
mg/unit
Non Haz Waste per Unit 144 180.06 229.5
2006 2007 2008
Page 22 of 54
9. Energy and Water Consumption.
9.1 Energy Consumption: 2006-2008
Energy Consumption - Gas/Electricity
0
2000
4000
6000
8000
10000
12000
14000
16000
18000
20000
Year
Energy (MWhr)
Gas MWhr 5699 6683 8248
ElectricityMWhr 9118 9517 9894
Total MWhr 14817 16200 18142
2006 2007 2008
The graph below normalizes the amount of energy consumed per unit of production ’06-‘08.
Energy Consumed / Unit Produced
0
1
2
3
4
5
6
7
Watt Hrs
Total Whr/unit 3.69 5.78 4.9
2006 2007 2008
Page 23 of 54
9.2 Water Consumption: 2006-2008
Water Consumption 2006-2008
0
2000
4000
6000
8000
10000
12000
14000
16000
Cubic Meters
Consumption m3 12780 8886 13892
2006 2007 2008
The graph below normalizes the amount of water consumed per unit of production ’05-‘07.
Water Consumption / Unit Produced
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
Cubic Meters
Consumption m3 4.3 2.8 3.7
2006 2007 2008
Page 24 of 54
10. Solvent Usage & Pollutant Release and Transfer Register
10.1 Summary Information: Solvent Usage 1998 - 2008
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
Usage (Tonnes)
Solvent Usage - Solid Dose Manufacture
Methylene Chloride 2,818 1,141 1,983 969.98 1038.31 802.56 1557.84 1010.92 919.44 734.15 1,003.20
Isopropanol 7,455 11,805 10,900 5853.45 4407.83 4092.77 4185.45 1882.329 1294 258.11 243.65
Methanol 876 122 0 0 0 0 0 0 0 0 0
Ethanol 0 0 0 0 0 0 0 0 0 0 2172.49
Total 11,149 13,068 12,833 6823.43 5446.14 4895.33 5743.29 2893.249 2213.44 992.26 3,419.34
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Teva Pharmaceuticals Ireland expects the solvent usage for 2009 to be considerably higher than
2008.
10.2 Pollutant Release and Transfer Register
The pollution releases and transfers set out in statutory instrument S.I. No. 123 of 2007, European
Communities (European Pollutant Release and Transfer Register) Regulations 2007 is reported
differently since 2007.
The PRTR information is now reported electronically via the AER Electronic Reporting interface
set up on the Environmental Protection Agency’s website. Appendix I is a summary of the PRTR
requirements as they relate to Teva Pharmaceuticals Ireland
11. Noise
A night-time and day-time noise monitoring survey was carried out in 2008 as per condition 8
(Noise) of the IPC Licence. Noise monitoring was undertaken at two site boundary locations (N1 &
N2) and two noise sensitive boundaries (NS1 & NS2) in the vicinity of the site.
11.1 Findings of Noise Survey Report
There are no major noise contributors for the Teva Pharmaceuticals Ireland site. The nearest noise
sensitive locations are a private residence and a residential estate near Teva Pharmaceuticals, which
lies beyond other factories operating within the industrial estate and would therefore be influenced
by many other sources.
Only one result was found to exceed the limit by more than 2dB(A), i.e. the night-time reading at
NS2. However, the main source of noise during the monitoring was the morning traffic on the
nearby roads (the survey was carried out from 6am). It is therefore the opinion of this report that the
company did not constitute a noise nuisance.
All the other readings were found to be compliant.
11.2 Noise Survey Report
See Appendix II for full noise survey report.
12 Environmental Complaints
There were no environmental complaints reported in 2008.
13. Management of the Activity.
13.1 ENVIRONMENT AND SAFETY OBJECTIVE # SHE 1:
Implement OHSAS 18001 and ISO 14001
REASON
To improve SHE performance and ensure that an ongoing continuous improvement philosophy is
translated into results
Reference: ISO 14001: 2004/OHSAS 18001:2007
PROJECT METHOD
STEP METHOD
1 Undertake Initial Status Review/Initial
Environmental Review
2 Draft EH&S Policy
3 Draft Register of Aspects
4 Review Risk Assessments
5 Draft, review and agree EH&S
Management Plan
6 Draft management systems manual
7 Identify certification body
8 Training and awareness for employees
9 Internal EHS audit programme
10 Management Review process
11 Conduct Pre-Assessment audit
12 Schedule certification audit
13.2 ENVIRONMENTAL OBJECTIVE # SHE 2
Page 27 of 54
Minimise the potential impact of hazardous materials on health and safety and on the environment.
REASON
Hazardous materials are highly regulated and are inherently hazardous to the environment and
health and safety.
Reg. of Aspects Reference: # 1 Hazardous Materials
Health and Safety Hazards: Ref. Chemical Risk Assessments, Task based assessments, ATEX risk
assessments, HAZOPs
Examples of Applicable Legislation:
� EC (Classification, Packaging, Labelling and Notification of Dangerous Substances)
Regulations 2003 and the European Communities (Classification, Packaging, Labelling and
Notification of Dangerous Substances) (Amendment) Regulations 2006, 2008
� REACH Regulation 1907/2006/EC
� Chemicals Act 2008
� Safety, Health and Welfare at Work (Chemical Agents) Regulations 2001
� 2007 Code of Practice for the Safety, Health and Welfare at Work (Chemical Agents)
Regulations 2001
PROJECT METHOD
STEP METHOD
1 Eliminate CFC use from site and replace with
HFA and ethanol
2 Decommission P12 Storage Tanks
3 Remove residual CFC (P11) from storage on
site
4 Minimise laboratory hazardous materials and
waste by implementing project plans (as
developed with PM)
5 Design, develop, construct and operate single
chemical store for TEVA with chemical and
API storage.
6 Upgrade existing chemical and API handling
� Install new containment equipment
� Ensure compliance with the TEVA
Corporate “Guidelines for Safe
Handling of APIs and Drugs”
(NWM66)
� Install and commission new
dispensing system with improved
containment
� Install and commission upgraded
central dust collection system
7 Dangerous Goods Safety Advisor audits and
action plans to be implemented
8 New hazardous materials management
procedure to be formalised in the system
9 Dangerous Goods software sourced and
implemented
10 Audit licensed dangerous materials hauliers
and ensure compliance
Page 28 of 54
13.3 ENVIRONMENTAL AND SAFETY OBJECTIVE # SHE 3
Minimise the impact of waste water emissions and eliminate the causes of non-compliances against
the waste water ELVs.
REASON To ensure that TEVA Pharmaceuticals reduces its overall environmental impact by addressing its most
significant environmental aspects Teva will ensure it is compliant with its IPPC License conditions and
minimises the impact of its waste water emissions.
Reg. of Aspects Reference: # 2 Waste water emissions
Legal and other requirements: IPPC License Reg. No. P0099-1
PROJECT METHOD
STEP METHOD 1 Investigate cause of phenol exceedences 2 Investigate the cause of COD exceedances
during 2007 3 Investigate the cause of ammonia
concentration exceedance 4 Review phenol license limit with the
Environmental Protection Agency based
on:
� Significant improvements over recent
years
� Probable link to API chemical
characteristics
� Existing ELV is an order of magnitude
below the ELV for comparable
pharmaceutical companies
� Cost of implementing further
reductions as against potential benefits
and possible alternative use of capital 5 Investigate equipment upgrade and/or
treatment options at the WWTP. Identify
project options and capital costs.
Page 29 of 54
13.4 ENVIRONMENTAL AND SAFETY OBJECTIVE # SHE 4
Reduce the impact of hazardous and non-hazardous waste on the environment and on employee
health and safety.
REASON
Hazardous waste and non-hazardous waste have been identified as the environmental aspects with
the 3rd and 4th most significant impacts on the environment, and constitute a very significant cost
to the company. In addition, hazardous waste retains the hazardous characteristics of the hazardous
materials which it contains.
Reference:
In addition to the legislation referenced under objective 2, the following selected waste
management legislation applies:
• National Recycling Strategy
• Waste Management (Amendment of Waste Management Act 1996) Regulations 1998 Waste
Management (Haz. Waste) Regulations 1998 and Waste Mgt (Haz. Waste) (Amendment)
Regulations 2000
• Waste Management (Movement of Hazardous Waste) Regulations 1998
• Waste Management (Shipments of Waste) Regulations 2007
• Waste Management (Waste Electric and Electronic Equipment) Regulations 2005 and
(Amendment) Regulations 2008
• Waste Management (Packaging) Regulations 2007
• Waste Management (Landfill Levy) Regulations 2008
PROJECT METHOD
STEP METHOD 1 Each department to set up waste reduction
and management teams 2 Each department to implement systems to
monitor waste generation and implement
reduction projects 3 Each department to supply monitoring
data to the EH&S department
Page 30 of 54
13.5 ENVIRONMENTAL AND SAFETY OBJECTIVE # SHE 5
Implement the energy management system IS 393.
REASON
Minimise the impact and cost of energy use at Teva Pharmaceuticals Ireland. Energy use has been
identified as the fifth most significant environmental impact at Teva Pharmaceuticals Ireland.
Reference:
IS 393
Register of Environmental Impacts
IVAX Pharmaceuticals (TEVA) AER 2007.
PROJECT METHOD
STEP METHOD 1 Obtain senior site management
commitment for certification to IS 393. 2 Agree project sponsor, project leader and
project team. 3 Draft Review of Energy Aspects 4 Prepare Register of Energy Legislation 5 Finalise Management Programme /
Develop corporate Objectives and
Targets. 6 Prepare Energy Management Systems
Manual 7 Identify certification body 8 Decide on target certification date
Page 31 of 54
Appendix I
Summary PRTR/AER Returns 2008
.3 RELEASES TO WASTEWATER OR SEWER
6 6
POLLUTANT
No. Annex II Name M/C/E
Method Code QUANTITY
71 Phenols (as total C) M PER
35 Dichloromethane (DCM) M PER T (Total) KG/Year A (Accidental) KG/Year
F (Fugitive) KG/Year
23 Lead and compounds (as Pb) M PER 1.825 1.825 0.0
13 Total phosphorus M PER 0.0 0.0 0.0
79 Chlorides (as Cl) M PER 0.0 0.0 0.0
68.28 68.28 0.0
306.0 306.0 0.0
POLLUTANT
Pollutant No. Name M/C/E
Method Code
238 Ammonia (as N) M PER QUANTITY
303 BOD M PER
306 COD M PER T (Total) KG/Year A (Accidental) KG/Year
F (Fugitive) KG/Year
314 Fats, Oils and Greases M PER 14.98 14.98 0.0
327 Nitrate (as N) M PER 1558.0 1558.0 0.0
343 Sulphate M PER 4913.0 4913.0 0.0
240 Suspended Solids M PER 131.0 131.0 0.0
52.9 52.9 0.0
309.0 309.0 0.0
499.0 499.0 0.0
Page 33 of 54
5. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE
Transfer Destination
European Waste Code Hazardous
Quantity T/Year Description of Waste
Waste Treatment Operation
Address of Recoverer / Disposer / Broker
Name and Address of Final Destination i.e. Final Recovery /
Disposal Site (HAZARDOUS WASTE ONLY)
Within the Country 20 03 01 No 274.56 General/Canteen Waste D1
Six Cross Roads Business Park, Lacken Road, Waterford
Within the Country 15 01 01 No 284.89 Cardboard R5
Six Cross Roads Business Park, Lacken Road, Waterford
Within the Country 15 01 02 No 106.49 Plastic (Bales) R5
Six Cross Roads Business Park, Lacken Road, Waterford
Within the Country 20 01 08 No 16.03 Compost R10
Six Cross Roads Business Park, Lacken Road, Waterford
Within the Country 20 01 01 No 101.46 Confidential Paper R5
Six Cross Roads Business Park, Lacken Road, Waterford
Within the Country 15 01 03 No 29.32 Timber Pallets R7
Six Cross Roads Business Park, Lacken Road, Waterford
Within the Country 15 01 07 No 10.56 Glass R5
Six Cross Roads Business Park, Lacken Road, Waterford
Within the Country 20 01 40 No 30.54 Scrap Metal R5
Six Cross Roads Business Park, Lacken Road, Waterford
To Other Countries 07 05 03 Yes 7.093 Chlorinated Solvents D10
Barretts Lane, Ardea, Co.Louth
Veolia, Bridges Road, Elesmere Port, Chesire, Uk
To Other Countries 07 05 04 Yes 44.72 Non Chlorinated Solvnets D10
Barretts Lane, Ardea, Co.Louth
Veolia, Bridges Road, Elesmere Port, Chesire, Uk
Page 34 of 54
To Other Countries 07 05 99 No 120.53
Table/Powder/Filter Waste D10
Barretts Lane, Ardea, Co.Louth
SAVA GmbH & Co., Ostertweute 1, Brunsbuttel, D25541, Germany
To Other Countries 16 05 08 Yes 0.778
Residual Laboratory Waste D10
Barretts Lane, Ardea, Co.Louth
SAVA GmbH & Co., Ostertweute 1, Brunsbuttel, D25541, Germany
Within the Country 15 01 10 Yes 1.582 Drums D9
Barretts Lane, Ardea, Co.Louth
AVR Safeway, Corrin, Fermoy, Co. Cork
To Other Countries 15 02 02 Yes 5.644 Filters D10
Barretts Lane, Ardea, Co.Louth
SAVA GmbH & Co., Ostertweute 1, Brunsbuttel, D25541, Germany
Within the Country 18 01 03 Yes 1.4448 Clinical Waste D9
Barretts Lane, Ardea, Co.Louth
EcoSafe Systems, Unit 1A, Allied Industrial Park, Kylemore Road, Dublin 10.
To Other Countries 16 05 07 Yes 0.249
Residual Laboratory Waste D10
Barretts Lane, Ardea, Co.Louth
SAVA GmbH & Co., Ostertweute 1, Brunsbuttel, D25541, Germany
Page 35 of 54
Appendix II
Noise Survey Report 2008
Tel: 353 1 276 1428 Fax: 353 1 276 1561 Email: [email protected]
www.enviro-consult.com
Registered Office as above. Registered Number 243 412
Environmental Noise Survey
For
Ivax Pharmaceuticals
Document Number: 853-03
Ivax Pharmaceuticals Environmental Noise Survey
Environmental Efficiency Page 38 of 54
Document No. 853-03 v1.00
QF 1. v2 Document Lead Sheet
Document Title Environmental Noise Survey
Project No. 853
Document No. 853-03
Client Ivax Pharmaceuticals
Address Unit 301, IDA Industrial Estate, Waterford, Co Waterford
Signed for and on behalf of Issue Status Date Author
Environmental Efficiency Client
1.00 Approved 18/12/2008 SR
Where it is a requirement that this report be issued to a regulatory or other authority, then the client should sign the
appropriate place in the above table and, unless specifically agreed in writing to the contrary, forward copies to the
appropriate authority (e.g. EPA).
EEC Project Manager: Bob Sutcliffe, CEng, MIMechE
EEC Document Author: Stephen Ryan, BA, MSC Env.
Conditions relating to the issue of this report:
1. No alteration to this report by third parties is permitted
2. Where this report is reproduced, it shall only be reproduced in full.
3. Reports remain the property of Environmental & Efficiency Consultants (Ireland) Limited until paid for in
full.
Ivax Pharmaceuticals Environmental Noise Survey
Environmental Efficiency Page 39 of 54
Document No. 853-03 v1.00
Summary of results
Office of Environmental Enforcement
PO Box 3000
Johnstown Castle Estate
Co Wexford
IPC Licence Number: 99
Company Name: Ivax Pharmaceuticals
Reporting Period: 2007
Report Name: Environmental Noise Survey
Were all results compliant with the terms of the IPPC licence? Yes No
√
Note 1: It should be noted that morning traffic on nearby roads was the main source
of noise and that it is the opinion of this report that the company did not constitute a
noise nuisance
Were any complaints received during this reporting period?
Yes No
√
Date 10/12/2008
Parameter Night-time Leq, t
Emission Point Reference NS2
No. of exceedences vs. No. of
samples N/A
Maximum Exceedence Value
vs. Limit Value
48.4dB(A) vs. 45dB(A) + 2dB(A) Note 1
Ivax Pharmaceuticals Environmental Noise Survey
Environmental Efficiency Page 40 of 54
Document No. 853-03 v1.00
Table of Contents
1. Introduction........................................................................................................................................ 41
2. Executive Summary ........................................................................................................................... 42
3. Sampling Methodology and Analytical Techniques........................................................................ 43
3.1 Instrumentation Used............................................................................................................ 43
3.2 Noise Survey Personnel ........................................................................................................ 43
3.3 Report Terminology.............................................................................................................. 43
3.4 Meteorological Conditions ................................................................................................... 44
3.5 Measurement Positions ......................................................................................................... 44
3.6 Measurement Locations ........................................................................................................ 44
4. Results ................................................................................................................................................. 46
5. Discussion ........................................................................................................................................... 50
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Document No. 853-03 v1.00
1. Introduction
Environmental Efficiency Consultants Limited were commissioned by Ivax Pharmaceuticals to carry out an
environmental noise survey on this site in order to assess the level of noise generated by the sites during normal
operation.
This day time and night time environmental noise survey was carried out on the10th December 2008, in accordance
with the EPA Environmental Noise Survey Guidance Document.
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Document No. 853-03 v1.00
2. Executive Summary
There are no major noise contributors for the Ivax Pharmaceuticals site. The nearest noise sensitive locations are a
private residence and a residential estate near Ivax Pharmaceuticals, which lies beyond other factories operating within
the industrial estate and would therefore be influenced by many other sources.
Only one result was found to exceed the limit by more than 2dB(A), i.e. the night-time reading at NS2. However, the
main source of noise during the monitoring was the morning traffic on the nearby roads (the survey was carried out
from 6am). It is therefore the opinion of this report that the company did not constitute a noise nuisance.
All the other readings were found to be compliant.
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Document No. 853-03 v1.00
3. Sampling Methodology and Analytical Techniques
3.1 Instrumentation Used
The following equipment was used during the noise assessment:
Table 1: Equipment Used
Equipment Model
(Cirrus)
Serial No.
Sound Level Meter (SLM) (Type 1),
(with windshield attached)
CR:811B C16569FD
Microphone MK:224 20020028
Calibrator CR:511E 035066
Tripod N/A N/A
The sound level metre was calibrated to 94 dB(A) on-site immediately before measurement and checked on completion
of the study. No drift in calibration level was noted.
The Certificates of Calibration for the SLM and calibrator are provided in Appendix 2.
3.2 Noise Survey Personnel
Noise survey was undertaken by Stephen Ryan, MSc Environmental Science.
3.3 Report Terminology
The parameters used to assess the noise are as follows:
Leq (t): is the continuous equivalent sound level over a specified time (t), where t represented a 15-minute
period during this survey. This measure is used to give an indication of the average noise level over
the specified time period.
Continuous: noise produced without interruption.
Intermittent: noise that is punctuated with interruptions e.g. equipment operating in cycles or events such as single
passing vehicle
Ivax Pharmaceuticals Environmental Noise Survey
Environmental Efficiency Page 44 of 54
Document No. 853-03 v1.00
Impulsive: a noise of short duration (typically less than one second), the sound
pressure of which is significantly higher than the background; brief and
abrupt.
Tonal: noise that contains a clearly audible tone i.e. a distinguishable, discrete or continuous note (whine,
hiss, hum or screech, etc.).
The noise measurements were ‘A’ weighted and the time-weighting ‘Fast’ was applied (to equate to human ear
hearing).
3.4 Meteorological Conditions
Weather conditions during the survey did not affect the readings i.e. conditions were dry and wind speed was less than
5 m/s (the normal upper limit for taking measurements). The Sound Level Meter was also fitted with a windshield to
minimise interference from meteorological conditions.
3.5 Measurement Positions
All measurements were taken at:
• 1.2 – 1.5 m height above local ground level
3.6 Measurement Locations
The locations of noise monitoring points are described in the following table. All readings were taken during operating
hours when nearby equipment was being used.
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Environmental Efficiency Page 45 of 54
Document No. 853-03 v1.00
Table 2: Location of sampling points for day and night survey (See Appendix 2)
Location Ref.
No. Geographical Description
N1 Southern boundary of Ivax facility
N2 North eastern boundary of Ivax facility
NS1 Eastern boundary of Industrial Estate, adjacent to Lismore
Park
NS2 Noise Sensitive Location at Eastern boundary of Industrial
Estate, adjacent to private residence.
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4. Results
The night-time monitoring was performed on the 10th December 2008 from 6am and the daytime monitoring was
performed on the same day from 9am.
Tables 3 and 4 show the measurement results for the monitoring locations at Ivax Pharmaceuticals. Associated
particulars such as a description of the noise, interferences/background noise recorded, in each location are also
provided in the table.
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Environmental Efficiency Page 47 of 54
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Table 3: Results of on-site day time noise monitoring.
Parameter Parameter Parameter Location
No* Time
Leq L10 L90
Description of On-site Noise Sources Description of Off-site Noise
Interferences
N1 15 minutes 63.3 65.9 55.2 Some traffic entering and exiting the
site.
Road traffic
N2 15 minutes 64.1 63.7 57.5 The chillers and compressors create
some noise.
Road traffic
NS1 15 minutes 46.7 47.7 40.3 Off-site traffic on nearby road was the
main source of noise
Road traffic was the main source
of noise.
NS2 15 minutes 46.3 49.6 44.2 Off-site traffic on nearby road was the
main source of noise
Road traffic was the main source
of noise.
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Document No. 853-03 v1.00
Table 4: Results of on-site night time noise monitoring.
Parameter Parameter Parameter Location
No* Time
Leq L10 L90
Description of On-site Noise Sources Description of Off-site Noise
Interference
N1 15 minutes 62.5 62.3 47.9 Off-site traffic on nearby road was the
main source of noise
Morning traffic on the nearby roads
was the main source of noise.
N2 15 minutes 62.3 62.3 56.7 The chillers and compressors create
some noise.
Morning traffic on the nearby roads
was the main source of noise.
NS1 15 minutes 46.7 47.7 40.3 Off-site traffic on nearby road was the
main source of noise
Morning traffic on the nearby roads
was the main source of noise.
NS2 15 minutes 48.4 49.1 39.3 Off-site traffic on nearby road was the
main source of noise
Morning traffic on the nearby roads
was the main source of noise.
Tel: 353 1 276 1428 Fax: 353 1 276 1561 Email: [email protected]
www.enviro-consult.com
Registered Office as above. Registered Number 243 412
5.
Tel: 353 1 276 1428 Fax: 353 1 276 1561 Email: [email protected]
www.enviro-consult.com
Registered Office as above. Registered Number 243 412
Discussion
All noise levels are relatively low at Ivax Pharmaceuticals. The limits are shown below.
Daytime: 55dB(A)
Night-time: 45dB(A)
A noise sensitive location is defined as:
Any dwelling house, hotel or hostel, health building, educational establishment, place of worship or entertainment, or
any other facility or area of high amenity which for its proper enjoyment requires the absence of noise at nuisance
levels.
The nearest noise sensitive locations are a private residence and a residential estate near Ivax Pharmaceuticals as can be
seen on the map in Appendix 2.
The day-time results of the noise survey are below the limit value of 55dB(A) at the noise sensitive locations (NS1 and
NS2).
The night-time noise levels at these noise sensitive locations were found to be slightly above the night-time limit of
45dB(A):
• At NS1: Leq, t = 46.7dB(A). This value does not exceed the limit value by more than 2dB(A) and is therefore
compliant according to Condition 3.4.1.
• At NS2: Leq, t = 48.4dB(A). This value is above the 2dB(A) allowance set out in Condition 3.4.1. However, the
main source of noise during the monitoring was the morning off-site traffic on the nearby roads and it is the
opinion of this report that the site did not constitute a noise nuisance.
Appendix 1 Certificate of calibration for the noise meter
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Appendix 2 Site map
Noise Sensitive Location