dEscRiPTiot4 OF THE PROPOSED DEVELOPMENT … · 2.0 dEscRiPTiot4 OF THE PROPOSED DEVELOPMENT ... was granted to the Polaroid Corporation for film ... WMI applied for permission 1996

2.0 dEscRiPTiot4 OF THE PROPOSED DEVELOPMENT

2.1 Site History, Context and Location

Site Historv

The lands in question were used for the production of cereal until 1978 when

planning permission (78/l 182) was granted to the Polaroid Corporation for film

making and camera manufacture, and in 1987 (87/65) to manufacture reflective

film for road signs. Permission was granted in 1989 for the change of use of

existing buildings (89/262).

Wyeth was granted planning permission in 1992 (910443) to produce and

package tablets.

On purchasing the site in 1991 Wyeth recognised that some existing structures

were generally suitable for the company’s immediate purposes but they were not

ideal in the long term. In this regard, WMI applied for permission in 1996

(Planning ref. no. 961374) to expand the facility to provide for a new warehouse

and to allow increased production of tablets and capsules. WMI applied for

permission in 1999 to extend the canteen (99/2193).

From 2000 to 2001 further developments occurred on site in the form of a new

main entrance sign (00/557), extension of Building 3 and bunded tank area

(01/1819), change of use for partial area of warehouse to production (01/791),

and retention of warehouse and car park extension (01/2263).

WMI is now considering a number of developments within the subject lands.

These developments are within varying stages of planning consent (from fully

granted to permissions, through to those still to be sought) and none has yet, as

of the date of submission of this document, been constructed on the site. These

are listed and fully described in Section 2.6 of this chapter.

Staffinu - EmrAovment 1 Workina Hours I Traffic Current operations within the WMI site involve the complete manufacturing and

packaging of a range of pharmaceutical products. The site operates 24 hours per

day, 7 days per week, with up to 1,100 employees and up to 150 contractors on

site between 8 am and 5 pm, with a much smaller number of employees being on

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employed at the facility. The site currently generates approximately 40 HGV

movements per day, 7 days per week. The majority of employees travel to work

by private car, with an average car occupancy of 1.6 employees per car.

Site Context

The WMI site at Newbridge is located within the townland of Little Connell

northeast of Newbridge town centre, adjacent to the R445 as shown on Figure

2.1. The current WMI landholding consists of 48.6 hectares, of which

approximately 22 hectares are attributed to the existing pharmaceutical

operations. The facility is currently accessed from the R 445 dual carriageway via

a roundabout and single access road.

The existing development within WMI is located principally within the north

western area of the WMI property with undeveloped space located in the

southern and eastern margins of the lands. These undeveloped lands are largely

Greenfield, comprised of agricultural and landscaped grasslands. The proposed

buildings relevant to this planning application and EIS are to be located adjacent

to the existing Building 3 as shown on Drawing No. 800235.02-DG-AR-PNF-AE-

003.

The WMI property is bounded to the north by the R 445, and to the west by a

county road (Greatconnell Road). Agricultural lands border the property to the

east and a Lidl distribution facility borders the property to the south. The

adjoining land uses include agriculture, the Oldconnell horse stud farm,

commercial and residential development. An area of residential development is

located across the road from the site, fronting onto Greatconnell Road.

2.2 The Applicant

As per the guidance of the formal scoping opinion from Kildare County Council

(Appendix 1.3), a full and detailed description concerning the applicant is

provided within the planning application documentation which accompanies this

EIS. However in order to place the proposed PNFX development in context, a

brief description of the principal activities are included within this section.

The WMI facility produces a variety of medical/pharmaceutical products, with the

principal products detailed in Table 2.1.

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Medical Category Product Name

Hormone Replacement Premarin, Premarin MPA, Prempack C, Premelle and Premique

Oral Contraceptives Harmonet, Trinordiol, Nordette, Ovranette, Minesse, Minulet, Loette

I--~ Gastrointestinal I Zoton I

1 Central Nervous System 1 Efexor, Efexor XR, Sonata, Tavor

Table 2.1 Principal Products Manufactured at WMI

Operations within WMI are based on formulation activities, consisting of blending

of raw materials, granulation, drying and coating processes, with subsequent

filling and packaging operations and product distribution from the site. There are

associated on-site warehouse facilities to provide storage facilities for raw

materials and final product.

Current production facilities comprise six main buildings;

l Administration

l Packaging

9 Tablet Manufacture

l Warehouse

. Utility Building

l Shipping & Receipt (ASRS)

Additionally there are areas dedicated to solvent recovery, combined heat &

power (CHP) and cooling towers.

2.3 Proposed Development

The proposed PNFX development consists of a planning application for a three

storey extension to the existing 38 manufacturing facility within WMI lands,

including office accommodation, ancillary site building, structures and site

services. The buildings within this development comprise a total footprint area of

8,110 m2 within the 49.7 hectare site application area.

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2.3.1 Constrkkion Phase Overview

The final details on how construction will be undertaken will be a decision for the

appointed contractor. It is therefore envisaged that there will be some flexibility in

the methods of construction to be used, subject at all times to compliance with the

planning permissions sought and all relevant statutory approvals. As part of the

contract requirements all construction contractors employed will be obliged to

implement high standards of housekeeping in order to minimise possible

environmental impacts. Environmental performance criteria or limits will form part

of contract documents. The likely construction methods are discussed below,

and the impacts of these construction methods are assessed in the relevant

sections of the EIS.

Site evaluation

An extensive programme of geotechnical site investigation works was undertaken

as part of the proposed PNFX site evaluation to obtain the information required to

produce appropriate foundations and sub-structures at individual building

development locations. The site investigation consisted of 10 trial pits and 13

boreholes, which were placed in the areas selected for the locations of the

proposed PNFX development and associated support buildings.

The site investigation works concluded that the site of the proposed PNFX

building and associated support buildings and structures is underlain by bands of

sand, gravel and clay, with some made ground, in the form of gravel, extending

along the north western boundary of the PNFX building. The ground was found

to be soft in places and it was recommended that excavation to approximately

3.2 m below ground level would be required, in order to expose a ground layer

suitable for construction of the foundation. It was also found that groundwater at

the site is subject to artesian pressure and may ingress to the excavation at

approximately the 3.2 m below ground level depth. A detailed discussion of the

site investigation is provided in Section 7.3 of Chapter 7 of this EIS.

It is proposed that a raft foundation structure be used to support the PNFX

building. This foundation will be suitable to safely support the loads imposed on

it.

Time of vear, duration and Dhasinq

The proposed construction programme will take approximately 18 ,months. The

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partial assembly off site, pre-cast slabs and specification of skid mounted

equipment, where possible, to maximise efficiency. The key construction

programme phases will be site preparation works, excavation, construction of

foundations, erection of structures, cladding of buildings, electrical and

mechanical fit out and commissioning, validation and start up.

1 Stage Timing I

Site Preparation I Months 1 -3 I

Main Civil Engineering Works Phase Months 2 - 8 I

Erection and Fabrication of Structures / Installation of

Equipment Months 4 - 12

Plant Commissioning & Testing Months 13 - 18 I

Table 2.2 Duration of Construction Works

Site Preaaration Works

Site preparation works will include topsoil stripping and storage, erection of

temporary hoarding and fencing where appropriate, creation of temporary

construction compounds and temporary site roads, welfare facilities, contractors

car park and laydown areas, and localised underground services diversion. This

element of work is expected to take approximately 3 months.

Emelovment

Employment levels will vary throughout the construction period depending upon

the operations being undertaken. It is estimated that some 850 construction

workers will be employed during the peak construction phase of the proposed

PNFX development.

Accommodation

Equipment and office housing facilities required during the construction phase will

be provided by the various contractors.

Requirements for local accommodation will depend on the level to which local

labour is employed. It is hoped that many of the construction workers will be

based in the local area. Workers will also most likely travel from Dublin and other

major centres of population, to the construction site.

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Typical construction hours are expected to be 7am to 6pm, Monday to Friday and

7am to 4pm on Saturday. However, it is likely that the contractor will wish to carry

out certain operations outside of these hours, from time to time i.e. during certain

stages of the construction programme some aspects of the work may extend to

late night and Sunday working. Such occurrences will be kept to a minimum and

take place over a short time-frame to avoid excessive disturbance as far as

possible.

Construction Techniaues

Construction techniques will include mechanical excavation, reinforced concrete

pad footings, structural steel braced frame, in situ concrete floor slabs, composite

cladding and block/brickwork and single ply roofing membrane, with insulation on

metal deck.

A comprehensive geotechnical site investigation has been carried out at the site

of the proposed PNFX development in order to obtain the information required to

produce appropriate foundations and sub-structures at individual building

development locations. The final foundation scheme to be adopted will be based

on the soil investigations and will be suitable to safely support the loads imposed

on it. The topsoil within the areas proposed for construction will be removed and

replaced with a layer of crushed stone to provide a working platform for

construction works. All pipework installation (for mains water supply, sewage

piping network) and associated excavations will be carried out using ‘best

engineering practices’.

The final details on how construction will be undertaken will be a decision for the

appointed contractor. As part of the contract requirements all construction

contractors employed will be obliged to implement high standards of

housekeeping in order to minimise possible environmental impacts.

The design and construction of the civil works will be to the standards applied in

the Irish construction industry. The work will be fit for the purpose intended and

comply with all requirements of a competent authority, Irish standards or Irish

standard codes of practices. Health and Safety procedures/protocols adopted in

the development will be carried out in accordance with all applicable National and

EU Regulations e.g. Safety Health and Welfare at Work (Construction)

Regulations 1995 (SI No. 138 of 1995).

Wyeth Medica Ireland Proposed PFNX Development Environmental Impact Statement

Description of the Proposed Development 2.6

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During construction it is planned that HGVs (material and equipment deliveries)

and cars (contractor personnel, developer personnel and visitors) will move to

and from the site via the proposed new signalised junction on the R445 and new

site access. The junction will be controlled by traffic lights, which will be phased

to ensure that the incidence of a queue developing on the R445 is minimised and

that the traffic related impacts of construction, are kept to a minimum. A full

description of this junction is provided in the Traffic Chapter of this EIS (chapter

12) which also addresses access for HGV traffic relating to the construction

phase which will only be permitted during certain hours.

Temporary car parking facilities will be provided within the site during the

construction phase. The temporary hard standing areas (car park and minor

access roads) will have an unbound hardcore surface.

Noise, Vibration and Dust

A range of noise control measures will be put in place to ensure the construction

related noise impacts are minimised. With regard to construction activities,

guidance is taken from BS5228: noise control on construction and open sites,

which offers detailed guidance on the control of noise and vibration from

demolition and construction activities. Various mitigation measures will be

considered and can be applied during the construction of the proposed PNFX

development, such as:

l Limiting the hours during which site activities likely to create high levels of

noise or vibration are permitted;

l Establishing channels of communication between the contractor/developer,

Local Authority and residents;

l Appointing a site representative responsible for matters relating to noise and

vibration;

l Monitoring levels of noise during critical periods and at sensitive locations;

and

l Keeping site roads reasonably even so as to mitigate the potential for

vibration from lorries.

Furthermore, it is envisaged that a variety of practicable noise control measures

will be employed. These may include:



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l Selection of plant with low inherent potential for generation of noise and/ or

vibration;

l Erection of barriers as necessary around items such as generators or high

duty compressors;

l Location of any noisy plant as far away from sensitive properties as permitted

by site constraints; and

l The use of vibration isolated support structures where necessary.

No significant vibrational impacts are expected as a result of construction

activities on site (see Noise and Vibration Chapter of this EIS, Chapter 10, for a

detailed discussion of noise and vibration impacts and mitigation measures).

The potential for dust to be emitted depends on the type of construction activity

being carried out in conjunction with environmental factors such as levels of

rainfall, wind speeds and wind direction. The potential for impact from dust

depends on the distance to potentially sensitive locations and whether the wind

can carry the dust to these locations. The majority of dust produced will be

deposited close to the generated source. A dust minimisation plan will be

formulated for the construction phase of the project, as construction activities are

likely to generate dust emissions.

In order to ensure that no dust nuisance occurs, a series of measures listed

below will be implemented:

l Wheel washing facilities will be provided for vehicles exiting the site in order

to ensure that mud and other wastes are not tracked onto public roads.

l Public roads outside the site will be regularly inspected for cleanliness, and

cleaned as necessary.

9 On-site hard surfaced roads will be swept to remove mud and aggregate

materials from their surface, while un-surfaced roads will be restricted to

essential site traffic only, apart from the contractor’s carpark which will be

hardcore only.

l Any internal road that has the potential to give rise to fugitive dust will be

regularly watered, as appropriate, during dry and I or windy conditions.

l Vehicles using site roads will have their speed restricted. On any un-surfaced

site roads, this is expected to be 20 kph, as well as on hard surfaced roads,

as site management dictates.

Wyeth Medica Ireland Proposed PFNX Development Environmental impact Statement


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l Vehicles delivering material with dust potential (soil, aggregates etc.) will be

dampened down, enclosed or covered with tarpaulin to restrict the escape of

dust.

l Material handling systems and on-site stockpiling of materials will be

designed and laid out to minimise exposure to wind. Water misting or sprays

will be used as required if particularly dusty activities are necessary during

dry or windy periods.

l During movement of materials both on and off-site, trucks will be stringently

covered with tarpaulin where necessary and practicable. Before entrance

onto public roads, trucks will be adequately inspected to ensure no potential

for dust emissions.

. At all relevant times, these procedures will be strictly monitored and

assessed. In the event of dust emissions occurring outside the site boundary,

movements of materials likely to raise dust will be assessed and satisfactory

procedures implemented to rectify the problem.

The dust minimisation plan will be reviewed by WMI and the Main Contractor at

regular intervals during the construction phase to ensure the effectiveness of the

procedures in place and to maintain the goal of minimisation of dust through the

use of best practice and procedures. A detailed description of the dust

minimisation plan is provided in the Air Chapter of the EIS, Chapter 9).

Water Discharaes

Welfare facilities will be provided for the contractors on site during the

construction works. These facilities will be connected to the existing foul drainage

system on site.

The sub-soil at the site is relatively permeable and the likelihood of surface water

collecting in excavations is low, except in localised areas where significant soil

compaction may have taken place due to regular trafficking of heavy machinery.

There is also a risk that groundwater ingress may occur, due to the relative

depths of the water table and the excavation.

Any surface water run-off collecting in excavations, or groundwater ingress to

excavations will be pumped from the excavation and treated by use of suitably

sized grit chambers and a 3 chamber Class I hydrocarbon interceptor prior to

discharge to a holding tank. Once the water is deemed to be uncontaminated



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with respect to suspended solids and hydrocarbons, it will be discharged in

compliance with the requirements of IPC Licence Register No. 673 (see Water

Chapter of this EIS, Chapter 8, for a full description of mitigation measures

proposed).

Extensions of infrastructure

A proposed new signalised junction on the R445 and new site access and car

parking will be constructed (for which permission has been applied for under

planning ref. 04/1428). No other infrastructure extensions are envisaged.

Materials (includina Sourcina. Tranwortation & Storaae)

Key materials will include steel, concrete, composite cladding, piping, electrical

cabling, process equipment and architectural finishes. A “Just In Time” delivery

system will operate to minimise storage of materials on site.

Sourcinq

General construction materials such as concrete, bricks, sand, gravel,

tarmacadam, asphalt and steel will be sourced from different areas throughout

the country. Where practicable it is proposed to source materials from the Kildare

area.

Storaae

Aggregate materials such as sands and gravels will be stored in clearly marked

bins within a secure compound area to prevent contamination. Liquid materials

will be stored within temporary bunded areas (all bunds will conform to standard

bunding specifications - BS8007-1987) to prevent spillage.

Tranwortation

Construction materials will be brought to the site by road. Construction materials

will be transported in clean vehicles. Lorries / trucks will be suitably enclosed or

covered during transportation of friable construction materials and spoil to prevent

the escape material along the public roadway.

PiDe Laving

Pipe laying will be carried out within the WMI site, and a connection will also be

required external to the site, to the proposed new 300 mm diameter water main

which Kildare County Council are proposing to construct and which will provide

potable water to the site.



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Fencing

The construction compound and temporary contractors facilities will be fenced off

from the remainder of the WMI site for health and safety reasons. During the

construction phase appropriate temporaly fencing will be erected to indicate the

routes to be taken by vehicles in order to minimise compaction of soils outside of

the areas proposed for development.

SDoil DeDosition

Excavated topsoil and subsoil will be stored on site and largely if not entirely

reused for landscaping purposes. Contractors will be required to submit and

adhere to a method statement indicating the extent of areas likely to be affected

and demonstrating that this is the minimum disturbance necessary to achieve the

required works.

Where soil stripping occurs the resulting excavated soil fractions will be separated

into topsoil and subsoil stockpiles. Temporary storage of spoil will be managed to

prevent accidental release of dust and uncontrolled surface water run-off which

may contain sediment and solid matter. Heavy vehicle movement and

construction works on exposed soils will be minimised during prolonged periods

of wet weather. Appropriate temporary fencing will be erected on site indicating

the routes to be taken by vehicles in order to minimise compaction of soils outside

of areas proposed for development. Machinery / equipment compounds and

heavy vehicle / machinery movements will be concentrated wherever possible on

areas proposed for future hard standing I impervious features i.e. roads buildings

etc. A full description of excavated materials is given in the Soil Chapter of this

EIS, Chapter 7.

Waste Manaaement

The handling and storage of construction wastes arising on site will be conducted

in full compliance with the requirements of WMI’s IPC Licence. It is anticipated

that construction activities will generate a range of waste materials, including

wood, concrete, steel, plastic, cement bags, cabling, damaged building materials,

waste paint and sealant containers.

The Main Contractor for the project will be required to operate a segregation

system on site, such that each waste is segregated in separate covered skips,

within a dedicated waste management area of the construction site. Materials will

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be sent off-site for recycling where possible and if not suitable for recycling,

materials will be disposed of to an appropriate waste disposal facility. All waste

movement, transport, recycling, recovery and disposal, will be carried out in

compliance with the requirements of the WMI IPC Licence.

2.3.2 Operational Phase Overview

The key objective of the proposed PNFX development is to add a high

containment solid dose manufacturing unit to the existing WMI facility which will

allow a transfer from the existing production of Premarin products to the

production of Premarin New formulation Products. The key difference between

Premarin and Premarin New Formulation is that Premarin is produced using

solvent-based technology (which consumes approximately two tonnes of

Industrial Methylated Spirits solvent per year), while Premarin New Formulafion is

produced using water-based technology.

The proposed PNFX development will comprise:

l A three-storey extension (approx. 1 8,000m2) to Building 3 containing:

--j Two high containment tablet manufacturing modules (Ml+M2);

+ Single process utilities and HVAC block (U) feeding both

manufacturing modules;

+ Single personnel access and gowning area (Gl) feeding both

manufacturing modules; and

+ Administration offices.

l A central utilities building (CUB) (1 ,760m2) containing:

+ Chillers;

+ Boilers;

---, Compressors;

--+ Electrical switchgear;

+ Water treatment equipment;

+ External equipment;

+- Cold store;

--z Diesel fuel tank;

--j External cooling towers and pumps;

+ Generators; and

--j Main water storage tank and equipment.

l An automated guided vehicle (AGV) route to the existing AGV feeding the

existing central automated warehouse (located within existing buildings).



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l A temporary construction compound over existing car parking space which

will revert to car parking within 18 months (3,875m2).

l A temporary construction compound over Greenfield which will revert to

Greenfield after 18 months (1 8,980m2).

The proposed new PNFX building will be a three storey steel construction in

keeping with the shape and look of the existing buildings. Approximate floor areas

for the interior of the manufacturing building are as listed in Table 2.3 below.

PNFX Level

1

General Purpose Gross Infernal Floor Area

Changing I Gowning Area and 6,294 m2 General Manufacturing

Materials Handling and Off ices 6,573 m2

1 Technical Support 1 5,112 m2

17,979 m2

Table 2.3 Gross Internal Floor Areas for PNFX

TvDe of Raw Materials

The principal raw materials that will be used at the PNFX facility are listed in

Table 2.4 below.

Nature of CAS Use Number

Quantity used

(kg/annum)

Quantity stored on site

(kg) 8,500

Storage Location

Premarin Production Premarin

Production Premarin

Production


Production


Production

Material

12126-59-g 50,000 Premarin CE and Lactose Lactose

Hydroxy Propyl Methyl Cellulose Hydroxy Propyl Cellulose Microcrystalline Cellulose Sucrose

Cold Store ASRS

ASRS

63-42-3

9004-67-5

200,000

92,000

34,000

15,500

2,250 ASRS 13,500

79,000 13,200 ASRS

227,000 38.000 ASRS

( ASRS MPA 71-58-9 500 100

Table 2.4 The principal raw materials that will be used at the PNFX facility. Note The ASRS is an on site warehousing facility

VVyeth Medica Ireland Proposed PFNX Development Environmental Impact Statement


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The products listed below in Table 2.5 will be exported from the site.

Table 2.5 Product to be exported from the PNFX facility

Formulation, Handlina and Transportation of Raw Materials and Products

Tablet making in simple terms involves the mixing of a certain dose of medicine,

referred to as an Active Pharmaceutical Ingredient (API), with an inert and

pharmaceutically in-active bulking agent (referred to as the excipient) such as

lactose, to produce tablets. The overall operation of the proposed development

will involve the mixing, blending, coating and drying of pharmaceutical active and

inactive ingredients using a water-based process.

The proposed new PNFX manufacturing facility will house an automated

equipment process, which will provide full containment of materials to Wyeth

REBC (Risk Based Exposure Control) guideline. The APls that will be used are

conjugated oestrogens and Mecfroxy Progesterone Acetate, which are both

hormones used in Hormone Replacement Therapy which are currently used on-

site and are contained in low concentrations in the solid dosage form tablet which

is produced. In their concentrated form these APls have a low OEL

(Occupational Exposure Limit) (OEL) and therefore are classified as highly

potent. The high potency and hence low OEL for these chemicals determines

that controls are required on the allowable overall exposure levels of the

compound in the working area, based on an eight hour time-weighted average.

To guarantee the highest levels of safety, the proposed PNFX development will

be built as a high containment facility to Wyeth RBEC level 4 giving the maximum

safeguard to the occupational health of WMI staff working on-site, and of the

external environment.

Two possible media for the potential escape of the APls to the natural

environment outside of the production building are via air through the air vent

system, or via water in small traces possibly contained in the wet washing of the

equipment. The design of the production building has taken account of these

factors by installing best practice air-quality abatement controls such as HEPA



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(High Efficiency Particulate Air) filtration and high efficiency dust minimisation and

collection systems.

The wash down waters will be first treated by an on-site waste water treatment

system designed to bring discharge levels well within IPC licensed emissions

limits. These discharges are then routed to the municipal foul sewer which is part

of the Kildare County Council sewerage network. This flows to the Osberstown

Waste Water Treatment plant.

In addition certain segregated streams will be collected on-site separately for off-

site treatment and disposal. All discharges will be fully compliant with WMI IPC

Licence No. 673 and any revision thereof.

The proposed three storey PNFX manufacturing building will be designed as a

vertically integrated tablet making facility, whereby material will ‘flow’ by

automated gravity fed processes downwards from the floors above. This process

which is summarised in Figure 2.2, will include the following steps:

l Raw Materials Dispensing

l High Shear Granulation Mixing and Milling

l Fluid Bed Drying and Milling

l Material Blending

l Tablet Compression

l Tablet Coating

Raw Materials Dispensing. Raw materials will arrive from the dispensing

section within the existing plant by means of an Automatic Guided Vehicle (AGV).

Raw materials (both API and excipient) will be charged into an Intermediate Bulk

Container (IBC) on Floor Level 2.

High Shear Granulation Mixing and Milling. From the IBC, materials (API and

excipient) are fed into a granulator where purified water is added and the material

is mixed and milled.

Fluid Bed Drying and Milling. After the materials have been mixed and milled,

the mixture is passed through a fluid bed dryer to dry off the water. The resultant

material leaves the fluid bed dryer as a granulate and flows by gravity via a mill

into another IBC.



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Mziterial’Blehditig. The IBC full of granulate is then placed in a blender, where it

is spun, ensuring a homogeneous mix.

Tablet Compression. The IBC from the Blender is then connected to a Tablet

Press from the floor above. The material is discharged into the tablet press

where the powder is compressed to form tablets. Compressed tablets are

ejected from the tablet press and stored in an IBC.

Tablet Coating. This is the final stage of the process whereby the compressed

uncoated tablets are fed from the IBC into a coater. The tablets are coated with

three successive solutions. Once with a sugar solution, then with a colour

solution and finally with a gloss solution. Once coated, tablets are unloaded from

the coater and transferred to a printing area within the existing WMI facility, where

they are marked with appropriate text.

The Central Utility Building (CUB) will contain the major utilities required by the

project. This building has been designed to provide hot water, steam,

compressed air, chilled water and mains water treatment for the requirements of

the process equipment associated with the proposed PNFX development.

2.3.3 Site Layout

The proposed development will be located adjacent and to the east of the

existing Building 38 as is shown on Drawing No. 800235.02-DG-AR-PNF-AE-

003. The PNFX production building will also necessitate the construction of a

Central Utilities Building, and an internal extension to the existing AGV route.

In addition to this, two temporary construction compounds will be required,

bringing the total development footprint to 32,115 m* (of which 24,000 m* will

be for temporary construction works) within the 49.7 hectare site application area.

2.3.4 Site Design

Buildinu Structure

The building shell for the proposed building will be a braced steel frame structure

and fire protected where necessary. The floors will be constructed of steel trowel

finished poured concrete on a profiled sheet type providing concrete decks at

6.3 m floor levels with an over flying roof steel and concrete structure.



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The floor deck heights have been deliberately aligned with those of the rest of

Building 3 to provide material access, personnel access and escape via the

existing flanking corridors and staircases.

The PNFX Floor Level 1 footprint, including the change rooms, new staff

entrance, link corridor, manufacturing modules and the Utilities/HVAC block, will

be approximately 73.0 m x 91.4m. It will step back at Floor Level 2 from the main

facade (plant north) by approximately 13.4 m. The grid is set at 9 m column

centres running plant east to west and between 8 m to 10 m running plant north

to south.

Wall cladding

Wall cladding will be part insulated brick and blockwork. To reflect the continuity

with Building 3 the brickwork will match the existing brown buff brick of Building

3B. The brickwork will be constructed up to a level of 8.4 m on the proposed

gable elevation (plant east) to tie in with the existing brick banding of Building 38.

Brickwork will be carried up on the stair and lift towers (plant north) to match the

soldier course level of the existing Building 3B. This will create a continuous sight

line of building materials between the existing Building 38 and the new proposed

facility. Pre-insulated cladding panels to match the existing panels of Building 3B

will be provided to all other areas. A double glazed polyester powder coated thin

frame window system will be provided to the personnel corridors on level two to

the plant north and south elevations. Fine line louvre systems will be provided for

HVAC2 intakes at Floor Level 2 and 3 and for the Utilities/HVAC block.

Curtain Walling

A glazed curtain walling system will be provided to the two-storey structure to the

northern elevation of the facility. This curtain walling system will enclose the

personnel link corridor on Floor Level I, linking the proposed PNFX facility with

the existing Buildings 38, 3A, 3 and Building 1. The curtain walling system is

carried up to Floor Level 1 via a spandrel panel (this will conceal the first floor

slab and steel beam support) to a brick parapet. The curtain walling will be

’ HVAC. Heat Ventilation Air Conditioning



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interrupted at regular intervals with brick piers providing internal display areas to

the link corridor and acting as fire breaks between the existing and proposed

structure. A brise soleil or solar fin will be installed below parapet level to provide

solar shading to the building occupants.

Roofing

Roofing systems are designed to ensure that all building mechanical systems are

internally provided for without the need for roof mounting, and that rain is directed

off and away from the building enclosure. This allows the provision of a

lightweight roofing system with areas of concrete slab for fire protection of

structure and construction laydown. The roof will be provided with a safety

access system.

2.3.5 Site Access

WMI has conducted a Strategic Review of Traffic Management at the Newbridge

Site over the past 12 months. The WMI site is currently accessed via an entrance

located on the western boundary of the site. As a result of the aforementioned

review, a planning application has been lodged with Kildare County Council

(04/l 248) to provide an additional site entrance and new signalised junction at the

north eastern corner of the site, initially to facilitate construction traffic currently

serving the site as part of the Building 3B development and PNFX construction

traffic, and in the longer term to facilitate employees accessing the site.

Should the application for the new site entrance not be successful, then WMI will

continue to use the construction site entrance adjoining the existing employee

entrance from the Greatconnell road.

Once construction works are complete, the new site entrance and related

signalised junction is planned to become a new employee and visitor entrance to

the WMI site. The new entrance will incorporate new site security barriers and a

security office, which will be sufficiently set back from the road to ensure that

HGVs stopping at the barrier do not impact on traffic on the R445.

On-site a new.staff entrance to the WMI facility will be created at the north east

corner of the proposed PNFX building. The proposed entrance is orientated

towards the proposed new site entrance (04/l 248) and road network.



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0 2.3.6 Traffic

The site currently generates approximately 40 HGV (Heavy Goods Vehicle)

movements per day, 7 days per week. The proposed PNFX development is

expected to give rise to an additional 2 - 4 HGV movements per day once

operational.

It is not proposed to provide car parking with this proposed development as the

car parking that is currently under the consideration of Kildare County Council

(04/1248) will adequately cater for its needs. Wyeth is also preparing a Mobility

Management Plan for the site, which will improve the sustainability of the

transport options available to employees accessing the site.

2.3.7 Waste Generation and Waste Management

As part of the general requirements of EU regulations, WMI will continue to

operate a distinct hierarchical approach to waste management for the proposed

PNFX and planned developments as follows:

l Prevention (Source reduction / elimination)

l Minimisation (Substitution)

l Reuse

l Recycling

l Energy Recovery (Treatment)

l Disposal

A waste management strategy will be developed for the proposed PNFX and

planned developments as per the requirements of Condition 7 of IPC Licence

Register No. 673 or any revised licence. To this end by strictly adhering to plant

operating instructions waste arisings at the plant should be minimal. Procedures

are specified for the management of contaminated raw materials i.e. if reusable,

material will be returned to material storage areas and I or the process system,

otherwise the material must be treated by appropriate means. All waste

generated at the site will be collected and stored in designated controlled storage

areas prior to removal by an appropriately licensed and EPA approved waste

management contractor for off-site treatment. No waste will be disposed of at the

site. Where possible metal, paper, cardboard, oil, wood or glass components will

be recycled (off-site).



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Both solid wastes and aqueous liquid wastes will be produced as part of the

normal operation of PNFX.

The solid waste stream will comprise the following:

CIP Wastewaters

Table 2.6 Predicted waste types generated from operation of PNFX (an asterisk

beside the EWC codes refers to waste being described as hazardous)

Waste actives and excipients will be generated by rejection of product and raw

materials, and from dust collection systems and equipment cleaning.

It is estimated that the PNFX waste streams (excluding waste actives and

excipients) will generate some 27 tonnes of waste per annum, all of which will be

classed as hazardous.

In addition, it is estimated that approximately 13 tonnes per annum of non-

hazardous waste, comprising cardboard, paper, plastic, metal, organic waste

from canteen and mixed residual non-hazardous wastes will be generated by the

additional 70 employees who will work on-site in PNFX.

Wyeth Meciica Ireland Proposed PFNX Development Environmental Impact Statement


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All waste disposal from PNFX will be as per the requirements of WMl’s IPC

Licence No. 673. (Condition 7) or any revised licence. Hazardous and non-

hazardous wastes are segregated on site and managed to ensure the potential

for contamination of the non-hazardous waste stream by hazardous waste is

removed.

Wastes will be directed from the point of generation to a dedicated waste storage

area within PNFX and will be transferred from this area to an appropriate area of

the existing on-site internal and external hazardous and non-hazardous waste

management compounds.

Only waste management contractors approved by the EPA will be used for

removal and disposal of wastes generated by PNFX, in compliance with the

requirements of WMl’s IPC Licence.

2.3.8 Water Discharges The following sources of wastewater generation will be present in the proposed

PNFX development:

l Effluents generated by the CIP (Clean In Place) systems which are used to

clean process equipment between batches;

l Rinse waters;

l Cooling tower make up water;

l Boiler blowdown;

l Water treatment reject waters; and

l Effluent from employees use of welfare and canteen facilities.

The wastewater stream will total some 197 m3 / day, of which some 103 m3 / day

will be generated by the CIP process. Of this it is expected that some 3 m3 / day

will be classed as hazardous waste and disposed off site at appropriately licensed

waste treatment facilities, in compliance with WMl’s IPC Licence.

The remainder will be disposed of via the new proposed on-site process

wastewater treatment plant, along with other effluents generated at the PNFX

facility.

It is expected that this system will be fully operational by January lSt 2006,

approximately 6 months before the PNFX development is planned to be fully

operational, in accordance with the requirements of the current IPC Licence for

the WMI site (IPC Licence No. 673). Domestic strength wastewater will be



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generated by employees working at the PNFX development. It is expected that

some 90 employees in total will work in the development, generating

approximately 4 m3 / day of wastewater, which will also be directed to the

proposed on-site wastewater treatment plant.

Surface water run off will be generated from rainwater falling on impermeable

surfaces at the proposed PNFX development. The run-off will be attenuated

using an attenuation tank to ensure there will be no nett increase in the surface

water run off rate at the WMI site.

213.9 Atmospheric Emissions

Process emissions will occur from the following emission points on the PNFX

facility:

l 3 no. boilers

l 2 no. granulators

9 2 no. fluid bed driers

l 16 no. tablet coaters

l 2 no. dust extract points

l 2 no. vacuum extract points

The following substances will be emitted and monitored from the boilers:

l Nitrogen dioxide (NO*)

l Sulphur Dioxide (S02)

l Carbon Monoxide (CO)

The following substances will be emitted and monitored from the other stacks:

l Total Dust (as PM,,-,)

All air emission points which have the potential to contain APls will be treated

through HEPA filters, which are designed to remove some 99.97% of all dusts

entering the filter.

In addition to exhaust air emissions from the HEPA filters, which could contain

traces of APls, the PNFX facility will also emit combustion emissions from the

operation of boilers (normally fuelled by gas and in emergency situations by oil).

The boiler combustion units will be fitted with low NOx burners (burners which

produce low concentrations of nitrogen oxides) to ensure the potential for

formation of NOx in the air emissions is kept to a minimum.



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All emission concentrations will be in compliance with the limit values defined by

the IPC Licence for the Site.

2.3.10 Services infrastructure

The site which is supplied by a 38kV electricity supply, is currently drawing

7.5 mVA. ESB has confirmed that infrastructure is adequate to meet the future

demands of the proposed PNFX development which will be an additional 4 mVA,

and also the future demands of other planned development which will account for

a further 3.1 mVA.

The steam boilers will be fuelled by natural gas and the emergency generator by

diesel. The predicted maximum gas usage will be in the region of 2250 m3 / hr.

Back-up generators will only be used when the electrical power supply to the site

is interrupted.

In addition to the ESB supply, WMI also operates a CHP plant (Combined Heat

and Power), which operates on natural gas and produces both electrical power

and waste heat, which is reused in the WMI facility.

The site is currently connected to the Newbridge town water supply and

sewerage systems. The facility currently receives some 500 m3 / day of

potable water and is licensed to discharge 450 m3 / day of wastewater.

As a result of the proposed PNFX development process water consumption will

rise from its current value of 500 my/day to 740 m3/day by the second quarter of

2006. Potable water demand from other planned developments is estimated to

increase by 250 m3/day by summer 2004. Kildare County Council has advised

that this proposed total increase of 490 m3/day will be met by its new 300 mm

diameter water main.

It is expected that wastewater production will rise from its current maximum value

of 450 m3 / d to 647m3 / d by the second quarter of 2006, as a result of the

operation of the PNFX development. Planned developments within the site will

give rise to an additional 130 m3/day, giving an overall predicted wastewater

production by second quarter 2006 of 777 m3/day. Kildare County Council advise

that the off site sewage infrastructure and Osberstown Wastewater Treatment

VQfeth Medica Ireland Proposed PFNX Development Environmental Impact Statement


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Plant will be able to accommodate this proposed increase in wastewater

production.

2.3.1 I Landscaping

Landscaping measures comprising two large planted berms are currently

under consideration by Kildare County Council as part of the planning

application no. 04/1248. Additional planting to areas of new build and new

pedestrian . routes will be provided as part of the proposed PNFX

development.

Mitigation measures have been incorporated at the design development stage to

minimise visual intrusion / obtrusiveness and integrate the proposed PNFX

development seamlessly into its surrounding semi-urban context. The scale and

height of the proposed PNFX development have been carefully considered and

designed to achieve a balance between making best use of the site without

dominating or compromising the surrounding area.

The proposed new PNFX facility will be in keeping with the existing external

finishes and emphasis has been given to minimising the building mass and the

development footprint of the proposed new facility.

Roofing systems have been designed to ensure that all building mechanical

systems are internally provided for without the need for roof mounting, and that

rain is directed off and away from the building enclosure. This allows the

provision of a lightweight roofing system with areas of concrete slab for fire

protection of structure and construction laydown.

The floor deck heights have been deliberately aligned with those of the rest of

Building 3 to provide material access, personnel access and escape via the

existing flanking corridors and staircases.

In keeping with the existing architectural context, wall cladding will be part

insulated brick and blockwork. To reflect the continuity with Building 3 the

brickwork will match the existing brown brick of Building 3B.

A new staff entrance will be created at the northeast corner of the PNFX facility. It

will create an appropriately appointed focal point for the new facility.



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The scale‘and intensity of the landscape works have also been designed to allow

the proposed development to conform to the character of the existing WMI site in

general. The building location was considered to minimise visual intrusion by

locating it adjacent to the existing buildings, and as such it will provide continuity

with the rest of the site when viewed from the eastern side of the facility.

The sensitive use of grading and planting to the north eastern fringes of the site is

also proposed in order to reduce the views into the site and provide an attractive

landscape setting for views into the WMI site.

Lighting will be designed to have a minimal impact on the environment. External

light sources will be designed to shine downwards, and will be designed to cause

minimum glare beyond the boundary of the WMI site.

2.3.12 Employment & Hours of Operation

The proposed development will require approximately 90 employees when

operational. The jobs will be highly skilled, and will involve specified training.

Of the approximate 90 employees, 5 will be office / administration staff and

the balance will be production staff, approximately 20 of whom will transition

from the existing Premarin facility and the remaining 70 of whom will be new

employees.

The coating process is 60-hours long and therefore a 24hr, seven days a

week three-cycle shift3 will be in place. Some of the peripheral processes

within the site will not be tied to the coating process, which may result in some

employees working a Monday to Friday 08:OO - 17:00 week.

2.3.13 Health and Safety

The proposed design of the PNFX development and additional planned

developments, has taken full account of the requirements of regulatory

authorities, the Building Regulations 1997 to 2000 (SI No. 497 of 1997 and * various amendments), construction industry guidelines and British Standards. In

addition the Safety, Healfh and We/fare (Construction) Regulations, 2001 and

Safety, Health and Welfare Work (General Application) Regulations, 1993 have

also been taken into consideration.

3 The three-cycle shift will run from 08:OO - 16:00, 16:00 - 24:00, 24:00 - 08:OO.

weth Medica Ireland Proposed PFNX Development Environmental Impact Statement


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Gene&l Principles of Prevention (First Schedule of the SHW (General

Amlication) Reauiations 1993)

Insofar as is reasonably practicable the facility and process design adheres to the

principles of the General Application Regulations 1993 including:

l The avoidance or risks.

l The evaluation of unavoidable risks.

l The combating of risks at source.

l The adaptation of work to the individual, especially with regard to the design

of places of work and the choice of work equipment.

l The choice of systems of work, with a view, in particular, to alleviating

monotonous work and work at a predetermined work rate.

l The adaptation of the place of work to technical progress.

l The replacement of dangerous articles, substances or systems of work by

non-dangerous or less dangerous articles, substances or systems of work.

l The development of an adequate prevention policy in relation to safety, health

and welfare at work, which takes account of technology, organisation of work,

working conditions, social factors and the influence of factors related to the

working environment.

l Giving collective protective measures priority over individual protective

measures.

l Provision of appropriate training and instructions to employees.

Process Safetv Review

A Process Safety Review was conducted by Fluor Ireland Ltd. which reviewed the

properties of the materials, containment strategy, and accident prevention. The

items reviewed’include:

l Hazards of the Activity or Procedure

l Previous Incidents

l Engineering and Administrative Controls

l Consequences of failures of Engineering and Administrative Controls

l Siting I layout issues

l Qualitative Evaluation of Safety & Health effects

. Other Regulatory Issues (OEL’s etc...)

l Material Problems

l External Effects or Influences



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l Operating Errors and Other Human Factors

l Analytical or Sampling Errors

l Equipment/Instrumentation Malfunction

l Process Upsets of Unspecified Origin

l Utility Failures

l Integrity Failure or Loss of Containment

l Emergency Operations

l Environmental Release

Fire Safetv

Fire detection and alarm systems were designed in accordance with Irish

Standards and Practice including:

l Technical Guidance Document B (TGD-B) of the Irish Building Regulations

l BS 5588-l 1 1997 Code of Practice for shops, offices, industrial, storage and

other similar buildings.

l 2000 International Building Code.

Smoke Manaaement

Smoke exhaust in the event of fire has been provided in the unclassified areas in

accordance with building regulations and insurers’ requirements. Similarly smoke

ventilation (to remove smoke from a building in the event of a fire) is provided in

all areas of the buildings which are larger than 300 m2 and which fall outside of

the controlled environments.

Fire Sutwression

Fire protection will be provided in accordance with the LPC (Loss Prevention

Council) Regulations, the 2000 International Building Code and insurers’

requirements. The existing fire mains will be extended as the existing fire pump

and storage tanks are adequately sized to meet the requirements of the

development. The new PNFX production building will be protected by an

automatically activated wet sprinkler system apart from the computer / server

rooms which will be protected by an automatically activated inert gas systems.

The Central Utilities Building (CUB) will be protected by an automatically

activated dry powder system. These automatic fire suppression systems will also



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be’supplemented by hand held fire extinguishers strategically placed around the

new development proposals.

Fire-Water Retention

Firewater generated by the hydrant system, sprinkler system or fire brigade fire

fighting equipment will be collected within the PNFX building by the process

drainage system and will be directed to the on-site fire water collection and

storage system. The maximum predicted volume of firewater which, it is

considered, could be generated by the PNFX development is I,21 9 m3, for a 90

minute fire event. The site currently has a firewater retention capacity of

1,000 m3 and this will be increased, as part of the proposed PNFX development,

by extending the existing underground 1000 m3 tank capacity to 1219 m3.

Firewater will be tested for pharmaceutical actives and other contaminants, prior

to release to the municipal sewerage system, via the WMI on site wastewater

treatment plant. A detailed discussion of firewater generation rates and volumes

is provided in the Water Chapter, Chapter 8, of this EIS.

2.4 Decommissioning

In the unlikely event of decommissioning and closure of the WMI facility the

provisions of the Residuals Management Plan (RMP) prepared for the site (which

has been approved by the EPA) will be adopted. The RMP is reviewed and

updated annually as part of the Annual Environmental Report (AER) prepared for

the site. The RMP incorporates a short term programme for decontaminating and

making safe all above ground structures and removing all wastes and hazardous

materials from the site and a long term programme which concentrates on

dealing with any soil or groundwater contamination issues associated with the

site.

It is expected that the RMP will be required to be reviewed and updated to

incorporate the proposed PNFX development.



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2.5

2.6 Other Planned Developments

Future ‘Grtitih And Expansion

Any further plant expansion found to be necessary will normally require additional

planning applications to be made. In turn, WMl’s IPC licence may require to be

reviewed and updated or revised. Such applications will be the subject of further

study based on the operation of the then current WMI site.

In order to adequately assess the cumulative impact of the proposed PNFX

development, additional developments which are planned for the site have been

assessed within the various chapters of this EIS. These additional developments

are detailed as follows and depicted on Drawing No. 800235.02-DG-AR-PNF-AE-

002.

DeveloDment Where Plannina Permissions Granted But Not Yet

Constructed:

l (0312097) Construction of a new enclosed plant room at roof level of the

existing Building 3 (222m2). The plant room will be constructed in two phases

each equating to 111 m2.

l (0312105) Installation of four new ventilation wall louvers to the south-east

elevation of Building 3.

l (03/2604) Modifications, additions and extensions to the existing Utilities

Facility on the site. These works are: new single storey extension (231m2) to

existing plant room Building 5A (530m2) housing electrical gear and

compressors etc.

l (03/1425) New single storey electrical switch room (206m2) and associated

transformers to be located in new extension to existing electrical compound.

Develooment Where Plannina AoDlication Lodaed But Not Yet Determined

bv Local Authoritv:

l (04/1248) Planning application for the provision of a new access, internal

road, additional 668 car parking spaces, new security building, temporary

construction area and landscaping provisions.



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Development ProDosed Where Plannina Awlication To Be Lodaed in the

Future:

l Proposal to construct a Waste Water Treatment Plant (WWTP). WMI plans

to submit this application in Quarter 3, 2004.

l Proposal to construct waste management compound. WMI plans to submit

this application in Quarter 3, 2004.

of the Proposed Development 2.30 Erkironmental Impact Statement

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Documents

dEscRiPTiot4 OF THE PROPOSED DEVELOPMENT … · 2.0 dEscRiPTiot4 OF THE PROPOSED DEVELOPMENT ... was granted to the Polaroid Corporation for film ... WMI applied for permission 1996