User Requirement Specification (URS)

For

Revision Date: February 18, 2013

Batch Style Glass Washer

Document Number:
URS-Glass Washer
 Citra-Labs
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USER REQUIREMENTS SPECIFICATION

1. Approvals

This document is the governing document for the user requirements for a system that will rinse
glass bottles and will be referred to as the “glass washer” or “the system” in this document.

The undersigned individuals acknowledge that they have read and fully understand Citra Labs
LLC. user requirements and corresponding Factory Acceptance Testing (“FAT”) requirements.

Conflicts between this URS and the attachments referenced herein shall be controlled by this
URS if applicable.

NAME JOB TITLE OR ROLE SIGNATURE DATE

The Author is signing to confirm acceptance of the documented rationale.

Author: Validation Engineer,

Matthew Hartman BWDG
The Manager, Manufacturing Engineering is signing to confirm acceptance of the specifications and documented rationale.

Approved by: Manager

John Tiani Manufacturing
Engineering
The Production Manager is signing to confirm acceptance of the specifications and documented rationale.

Approved by:
Production Manager
Dhar Bharatula
The Quality Asssurance Manager is signing to confirm acceptance of the specifications and documented rationale.

Approved by: Manager, Quality

Chris Hawley Assurance

This document is the property of Citra Labs LLC. The information is private and confidential
and is to be used only in occurrence with work directed by Citra Labs LLC. and no part of this to
be disclosed to others without written permission from Citra Labe LLC. Braintree, MA

1. Approvals....................................................................................................................2
2. Revision History.........................................................................................................4
3. Use of the User Requirement Specification (URS).................................................5
4. Purpose.......................................................................................................................5
5. References...................................................................................................................6
6. Equipment/System.....................................................................................................6
7. Product........................................................................................................................7
8. Performance Requirements......................................................................................8
9. Functional Requirements........................................................................................10
10. Power Failure and Recovery Requirements.......................................................10
11. Utilities Requirements..........................................................................................11

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12. Cleaning Requirements........................................................................................11

13. Safety Requirements.............................................................................................11
14. User Interface Requirements...............................................................................13
15. Computer System Requirements.........................................................................14
16. Electrical Requirements.......................................................................................15
17. Mechanical Requirements....................................................................................16
18. Physical Installation Requirements.....................................................................18
19. Documentation Requirements.............................................................................18
20. Equipment Testing Requirements.......................................................................19
21. Attachments...........................................................................................................19

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USER REQUIREMENTS SPECIFICATION

2. Revision History
Date of
Revision Revised By Title/Department Description of Change
Revision
Validation Engineer
A 02/08/2013 Matthew Hartman Barry-Wehmiller Design Issued for Review
Group
Validation Engineer Incorporated Vendor
B 02/18/2013 Matthew Hartman Barry-Wehmiller Design Exceptions. Issued for
Group Approval.

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USER REQUIREMENTS SPECIFICATION

3. Use of the User Requirement Specification (URS)

This document represents the requirements for a new batch style glass washer. The requirements
have been solicited by Biomet/Citra Labs, LLC. (Hereinafter referred to as Citra Labs) from the
key users and stakeholders of the proposed system. These requirements are communicated to the
supplier to enable the supplier to quote, specify and build the system which includes but is not
limited to design, manufacture and test.

Citra Labs approval of the URS constitutes agreement by key users and stakeholders that all user
requirements are fairly and accurately represented. Any system designed and implemented in
accordance with the URS must meet the requirements listed herein. If the system does not meet a
listed requirement, justification must be provided to the key users and stakeholders for modifying
the specification. Acceptance by the key users and stakeholder of any changes must be
documented, along with the justification, and this URS must be updated, approved and re-issued.

Supplier-identified exceptions to this URS must be itemized in detail on the exception list by the
supplier in a timely manner and discussed and agreed with Citra Labs prior to any purchase order
being issued. In the event that no supplier exceptions are identified, it is understood that the URS
is acceptable in full as written. See Attachment 01 – Exception List.

4. Purpose
The purpose of this URS document is to define the user requirements for the batch style glass
washer. In this document it will be referred to as “the system.” The system is designed to rinse
glass bottles prior to depyrogenation and then filling with product.

This URS includes the requirements for the design, operation, and applicable performance
characteristics necessary to function as intended. The system will be fabricated, installed, and
verified to operate to the specifications outlined in this document. This URS is prepared by
Barry-Wehmiller Design Group (BWDG), representing Citra Labs.

The supplier shall accommodate the FAT package and deliver the system in accordance with this
specification, terms and conditions, and the accompanying information provided by Citra Labs.

This equipment will be installed and located at the Citra Labs Facility in Braintree, MA.

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This document will provide the following details and specifications:

 Description of the incoming in-process materials and outgoing finished products

 Description of the design and function of the system
 Definition of equipment requirements with regard to:
o System performance
o System acceptance criteria
o System design considerations
o Safety and environmental factors

5. References
The equipment will be designed for compliance with the practices and principles as described in
the following guides:
 GAMP 5
 ISPE Baseline - Commissioning and Qualification
 CE Conformity with the European Union Regulations
 FDA Food and Drug Administration
 NEMA - National Electrical Manufacturers Association
 OSHA - Occupational and Safety Hazard Administration
 UL - Underwrites Laboratories

6. Equipment/System

6.1. Overview
 The system will be installed in an ISO 8 environmentally controlled room.
 The system will process 110 bottles per load for the 30mL bottle size. Additionally,
the system will be capable of (although not provided with the change parts for)
processing 284 bottles per load for the 5mL bottle size and 60 bottles per load for the
50mL bottle size.
 The system will be capable of rinsing all internal and external surfaces of the bottles.
 The system will be able to provide a multiple stage bottle rinse and air blowing cycle.
 Water for Injection (WFI) will be drawn directly from the WFI supply loop at 80°C.
 Compressed air for the bottle air blowing cycle will be 0.2 micron filtered.
 The complete System shall include, at a minimum:
o 316L stainless steel injection needles, piping, basin, and top cover.
o One loading plate of 316L stainless steel for 30mL. Additionaly, the system must
be capable of housing plates to rinse 5 mL and 50 mL vials.
o 304 stainless steel exterior. All external surfaces, including base, must be
compatible with materials of cleaning.
o The glass washer will have an independent human machine interface (HMI) and
programmable logic controller (PLC).

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6.2. Description
The system will employ a series of WFI and filtered air injections to rinse the internal and
external surfaces of the bottles. The operation of the system will be controlled and monitored
by a dedicated PLC. The operator will have access to the system control, status, alarms, and
messages by use of a dedicated HMI.

To initiate the cycle, the operator will manually de-bag and load bottles onto the loading
plate. Once fully populated, the operator will then insert the loading plate into the glass
washer through the top hatch and secure the hatch closed. The operator will then select the
appropriate cycle from the HMI and activate the system by pressing the start button.

The bottles will be subjected to a series of internal rinse and air blowing sequences delivered
through stainless steel injection needles centered on the interior of each bottle. External
surfaces will undergo a rinse and air blowing sequence delivered by rotating wands situated
above the bottles. WFI will be used for each rinse sequence. After each rinse sequence, the
bottles will be air blowed by filtered, compressed air. Following a successful completed
cycle, the operator will remove the loading plate with the rinsed bottles from the glass
washer.

6.3. Applicable GMP Requirements

All equipment shall be in compliance with Current Good Manufacturing Practices.

7. Product
The system will handle, rinse, and air blow 30mL glass bottles and be capable of rinsing 5 mL
and 50 mL glass bottles utilizing different needle plates. See Attachment 02 – Bottle Drawings
for detailed bottle drawings.

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8. Performance Requirements

8.1. General Performance

ID Number Requirement Description
The system shall be capable of processing 110 bottles per load for the
30mL bottle size. Additionally, the system will be capable of (although
URS-ID-1
not provided with the change parts for) processing 284 bottles per load
for the 5mL bottle size and 60 bottles per load for the 50mL bottle size.
The system must not experience more than 1.0% downtime due to system
URS-ID-2
failure during normal operation over a course of 8 hours.
The system must have a quality acceptance rate of 99.9% or greater over
a course of 8 hours. Quality acceptance is defined as undamaged bottles
URS-ID-3
with no visible evidence of contaminants such as glass, oil, grease, or
visible particulates.
All product contact parts shall be constructed from materials acceptable
to the product and cleanliness requirements. Certificates for material,
URS-ID-4
weld, and finish shall be provided. Product contact parts are defined as
those that transport WFI, filtered air, and handle bottles.
The injection needles must be centered on and must not rub against,
URS-ID-5
compress, or otherwise make contact with the bottles.
The design of the equipment shall not incorporate any system that could
URS-ID-6 potentially shed particulate or foreign matter or introduce particulate or
foreign matter into the bottles being processed.
The operation shall occur without causing disorientation, scratches,
URS-ID-7
chipping, cracks, or any damage to any part of the bottles.

8.2. Rinsing
ID Number Requirement Description
The system shall be capable of rinsing all internal and external surfaces of
URS-ID-8
the bottles.
The system shall be capable of rinsing away all visually detectable levels
URS-ID-9 of particles, dirt, dust, packaging materials, or other contaminants on the
bottles.

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8.2. Rinsing
ID Number Requirement Description
The system shall pass riboflavin testing as follows:
 A homogeneous solution of riboflavin (consisting of 1 gram of
riboflavin per 10 liters of cold WFI) shall be slowly sprayed on
the interior top and side walls of the glass bottles. Excess will be
drained.
 The bottles will undergo a pre-rinse visual inspection with a long-
URS-ID-10 range wave-length UV lamp for uncovered spots, sprayed again
(as needed), and drained again (as needed).
 The bottles will undergo the rinse cycle.
 After the rinse cycle, the longrange wavelength UV lamp will be
used for a post-rinse inspection, checking for remaining traces of
riboflavin. There shall be no traces of riboflavin on the glass
bottles after the rinse cycle.

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9. Functional Requirements

9.1. General Functional

ID Number Requirement Description
The system shall be capable of providing the rinsing requirements in a
URS-ID-11
maximum 01:30 minute cycle time.
Equipment shall be capable of running 2 shifts per day, 5 days per week,
URS-ID-12
and 48 weeks per year.
The operation of the system shall be semi-automated, requiring a single
URS-ID-13 operator to insert the loading plate, initiate the cycle, and remove the
loading plate.
The operator shall insert and remove the loading plate from the top hatch
URS-ID-14
of the glass washer.
A 316L stainless steel loading plate shall be provided for 30mL bottle
URS-ID-15 size. The plate shall be designed with the same footprint as the staggered
bottle packaging configurations in Attachment 02.
The system shall be designed to accommodate 30mL bottle size and
URS-ID-16
configurations as identified in Attachment 02.
All temperature and pressure sensors must be calibrated to NIST
URS-ID-17
traceable standards.

9.2. Operation
ID Number Requirement Description
The system shall be capable of running programmable, multi-stage rinse
URS-ID-18
and air blow cycles (up to 18 stages).
URS-ID-19 The system cycle shall be initiated by the push of a single start button.
The system shall be equipped with an HMI that provides cycle control,
URS-ID-20
system status, alarms, messages and reset capabilities.

10. Power Failure and Recovery Requirements

10.1. Power Failure and Recovery

ID Number Requirement Description
On power failure, the system shall fail to a safe state in which all motion
and rinse functions are stopped without compromising operator safety or
URS-ID-21
product quality. On power restoration, the system shall require a manual
reset prior to re-starting the system.
URS-ID-22 System must retain PLC program at loss of power or communication.

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11. Utilities Requirements

11.1. Utilities
ID Number Requirement Description
The system shall be designed and fabricated to operate using the
following available primary utilities:
URS-ID-23 Electrical Power: 120VAC, 60 Hz, Single-Phase
Clean Compressed Air: 90 PSI
WFI: 10-50 PSI, 80°C, 0.1 GPM per Nozzle
All power and compressed air for the equipment will be connected in the
URS-ID-24
clean room area.
URS-ID-25 Drainage shall be adequate to prevent back-up.

12. Cleaning Requirements

12.1. Cleaning
ID Number Requirement Description
All exterior surfaces will be smooth and free of catch points to permit
URS-ID-26
ease of wipe-down cleaning and sanitation procedures.
All surfaces, including base frame, shall be compatible with Septihol or
URS-ID-27
equivalent.

13. Safety Requirements

13.1. General Safety

ID Number Requirement Description
The supplier shall eliminate system hazards or reduce the associated risks
as far as practical by eliminating dangerous parts and conditions. The
supplier shall warn about hazards that cannot be eliminated even if they
URS-ID-28
are protected by safeguarding. These hazards shall be clearly indicated
by warning signs or markings in English, and firmly attached to the
system.
The entire system shall be designed in accordance with all applicable
URS-ID-29
OSHA requirements.
URS-ID-30 All equipment and devices shall fail in a safe, de-energized, mode.
All sharp edges and fabrication burrs throughout the entire system shall
URS-ID-31
be cleaned and removed.
If any conditions exist which may pose a risk to operator, production or
URS-ID-32 equipment those conditions must be corrected prior to system acceptance
in supplier’s plant.
URS-ID-33 All pinch points must be guarded to protect operating personnel.
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13.2. Safety Interlocks

ID Number Requirement Description
URS-ID-34 The top hatch shall be equipped with a safety interlock switch.
All the safety interlocks shall stop motion of all moving parts, stop
URS-ID-35 injecting WFI and/or air, and remove or control all hazardous energy
sources prior to access to the system.
URS-ID-36 All interlocks shall require a reset action to resume equipment activation.
URS-ID-37 There shall be NO safety interlock bypass when in operation.

13.3. E-Stops
ID Number Requirement Description
The system shall contain minimally one E-stop button located at the
URS-ID-38
operator interface for hard stop of the equipment.
The E-Stop system shall stop motion of all moving parts and remove or
URS-ID-39 control all hazardous energy sources before someone could reach a
hazard.
The system shall be designed to handle the stress of an emergency stop
URS-ID-40
without damage.
URS-ID-41 The E-Stop mechanism shall override all other system controls.
The E-Stop mechanism shall require a manual reset prior to re-starting the
URS-ID-42
system.

13.4. Lockout
ID Number Requirement Description
The electrical panel is to be provided with a UL approved disconnect
URS-ID-43
switch which will disconnect the utility power.

13.5. Ergonomics and Human Factors

ID Number Requirement Description
The system operating noise must not exceed 85db as measured 3 feet
URS-ID-44 from any equipment component at operator head level per OSHA
standard.

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13.5. Ergonomics and Human Factors

ID Number Requirement Description
The system shall include good safety and ergonomic design features that
ensure operator safety and convenience. All material loading, unloading
and clearing points, control system interfaces and emergency stops shall
be located for operator’s convenience and best ergonomic practices
between the knee and chest of a person of average height. Further,
operating the equipment shall not require:
URS-ID-45  Frequent and repetitive motions of any type
 Bending or twisting of wrists
 Twisting or flexing of the back
 Reaching behind the body
 Lifting objects weighing more than 15 lbs above the shoulders
 Working with a bent neck
 Lifting or manipulating loads greater in weight than 20 pounds

14. User Interface Requirements

14.1. Security
ID Number Requirement Description
The HMI, at a minimum, shall display controls, system status, alarms,
URS-ID-46
and messages.
Three levels of password protected screens must be provided as follows:
 Default (No Password): System status, alarms, and messages.
URS-ID-47  Operator: In addition to default capabilities, cycle controls.
 Administrator: In addition to Operator capabilities, cycle
parameter adjustment.
Operator and Administrator screens must have a time out function that
URS-ID-48 reverts to the login screen after a period of inactivity no greater than 15
minutes.

14.2. Faults/Alarms
ID Number Requirement Description
URS-ID-49 Sensors for alarm and fault conditions shall be included.
User documentation must include a list of the possible error or fault
URS-ID-50 conditions, the corresponding error codes, disposition, means of
triggering alarms, and reset sequence.

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14.2. Faults/Alarms
ID Number Requirement Description
The system shall provide alarms for:
URS-ID-51
 Emergency stop

15. Computer System Requirements

15.1. Control Hardware

ID Number Requirement Description
URS-ID-52 The PLC shall be Allen-Bradley Compact Logix.
URS-ID-53 The HMI shall be Allen-Bradley PanelView.
A minimum of 10% spare I/O capacity (analog and digital) shall be
URS-ID-54
provided for the PLC.

15.2. Control Software

ID Number Requirement Description
Controls for the system shall comply with 21 CFR, Part 11 of the FDA
URS-ID-55 cGMP regulations. The supplier shall stipulate the methods by which this
criterion is met.
The parameters for each operation must have a pre-defined range. The
range can only be modified through PLC programming. The parameter
URS-ID-56
may be adjustable within this range. The number of parameters for each
operation is fixed.
Dead code, which is code that cannot be executed due to the logic of the
URS-ID-57 program, shall be eliminated from the software where feasible. Supplier
shall submit a certificate of conformance to this effect.

15.3. Data
ID Number Requirement Description
System PLC shall be capable of communicating with client’s network via
URS-ID-58
Ethernet Protocol.
Provide an Ethernet Hub within the Control Panel that has allowance for
URS-ID-59 client’s network Ethernet cable to be plugged in, as well as one spare port
for diagnostic purposes.

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15.4. Disaster Recovery

ID Number Requirement Description
The system supplier shall provide a complete backup copy of the main
URS-ID-60 program and subroutines as well as documented step by step instructions
for system recovery.

16. Electrical Requirements

16.1. General Electrical

ID Number Requirement Description
URS-ID-61 All electrical panels are to be UL rated, NEMA 4x.
All power wiring shall be complete, requiring only the installation of a
URS-ID-62
single electrical service for equipment operation.
The manufacturer shall provide transformers to reduce incoming power to
URS-ID-63
required control and instrument voltages.
Each wire, conductor terminal and connecting block shall be numbered
URS-ID-64
and referenced on approved electrical schematics.
All high voltage contactors, terminal strips, relays and motor controls
shall be installed in a stainless steel NEMA 4x enclosure. All switches,
URS-ID-65 etc., mounted to the face of the enclosure shall be rated as splash proof.
All electrical enclosures shall be labeled as to the electrical danger and
voltage each contains.
The system must not be affected by radio frequency interference (RFI) or
URS-ID-66 electromagnetic interference (EMI) generated by adjacent equipment in
the packaging area.

16.2. Wiring
ID Number Requirement Description
Not more than two wires shall be connected to any side of a terminal
URS-ID-67
block.
10% reserve terminals, including power and controls in each panel, shall
URS-ID-68
be provided.
URS-ID-69 Power and control wiring shall be routed separately.
URS-ID-70 Conductors must run from terminal to terminal without splices.
Individual shields shall be provided for all analog twisted pairs leaving
URS-ID-71
the PLC panel.
Shields shall run from the instrument to the PLC panel. Shields shall be
URS-ID-72
grounded at the PLC panel only.

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16.2. Wiring
ID Number Requirement Description
Each field device feedback signal shall be committed to a single
URS-ID-73
controller input.
URS-ID-74 Only one output device shall be wired to any single controller output.
Each field device shall be labeled in English in a manner that makes it
URS-ID-75
easy to relate to the electrical schematics and the controller program.
Field device wires shall be clearly identified by a durable method.
URS-ID-76
Markings shall correspond with the Supplier's drawings.
Each field device shall have a continuous connection to the main control
URS-ID-77 panel. Daisy chaining of power and return in the field is not permitted,
except in the case of the “E-Stop” circuit.
Controller I/O wiring shall be numbered in a manner that references its
URS-ID-78
address on the I/O module.
URS-ID-79 Wire ferules will be used for all terminal block terminations.
The use of wire nuts, solderless splices, or crimp splices is prohibited; all
URS-ID-80
wire connections will be done with terminal blocks.
Wires shall be numbered on both ends, in a method corresponding to the
URS-ID-81
electrical schematics.
All wiring shall be installed in plastic troughs (wireway). A minimum of
URS-ID-82 30% spare space shall be provided in the wireway. Wires shall be neatly
bundled and secured within the wireway.

17. Mechanical Requirements

17.1. Maintenance
ID Number Requirement Description
A list of the spare parts expected to be required within the first year of
URS-ID-83 operation, along with the spare part numbers, prices and quantities
required shall be provided.
Substances required for operation of the system, such as lubricants, shall
URS-ID-84
not contact product.
All lubricants must be approved by the FDA for incidental or direct
URS-ID-85
product contact and shall be non-flammable.
All bearings, gearboxes and other mechanical contact surfaces requiring
URS-ID-86 lubrication must be per the manufacturer’s specification prior to start-up
and operation of the equipment.
URS-ID-87 All lubrication points shall be easily accessible.

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17.2. System Structure

ID Number Requirement Description
All welds on exposed surfaces shall be continuous and ground smooth.
URS-ID-88
All corners are to be rounded.
System shall sit on adjustable height stainless feet capable of angular
URS-ID-89
leveling and +/- 2 inches of height adjustment.
All motors shall have permanent nameplates bearing, at a minimum, the
URS-ID-90 manufacturer’s name, model and serial numbers, horsepower, voltage,
current and phase requirements and service factor.
System exterior dimensions (including HMI) shall be no greater than 48”
URS-ID-91
x 30” x 72”.

17.3. Materials of Construction

ID Number Requirement Description
Materials that absorb or are not compatible with Septihol, LpH se,
URS-ID-92 Vesphene, Spor-Klenz, or equivalants shall not be used within this
system.
Internal chamber surfaces including spray needles, piping, basin, top
URS-ID-93 cover, and loading plates shall be fabricated from 316L stainless steel,
max 50 Ra finish.
Materials in direct contact with the product shall not have the potential to
URS-ID-94 alter the safety, identity, strength, purity or quality of the product through
absorption, addition or reaction.

17.4. Pneumatics
ID Number Requirement Description
All pressure regulators, air filters, etc., required shall be part of
URS-ID-95 equipment, and located together at a convenient location for periodic
adjustments and service.
URS-ID-96 Equipment shall have only one inlet for compressed air source.
URS-ID-97 All air exhausts shall be silenced as long as function is not compromised.

PAGE Citra-Labs USER REQUIREMENTS SPECIFICATION

Braintree, MA 02184 REV REV DATE
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B 02/18/2013 Batch Style Glass Washer URS-Glass Washer
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 Citra-Labs
Braintree, MA
USER REQUIREMENTS SPECIFICATION

18. Physical Installation Requirements

18.1. Physical Installation

ID Number Requirement Description
The system will be installed within an existing facility on Messina Drive
in Braintree, MA and will be received through a typical loading dock
URS-ID-98 through an over head door. The equipment must comply with Citra Labs
access restrictions once unloaded at the facility with minimal disassembly
of the equipment.

19. Documentation Requirements

19.1. Documentation
ID Number Requirement Description
All manuals and drawing text must be in English supplied in PDF format.
URS-ID-99
Drawings shall be supplied in AutoCAD compatible format.
Documentation from the supplier shall include:
 Model/Serial Number of equipment on the Operations Manual
 Process and Instrumentation Diagram (P&ID)
 Application Software – Electronic copy – of all PLC and
applicable HMI programs.
 Electrical Drawings
 Pneumatic Drawings
 Layout Drawings
 List of devices requiring calibration
 Bill of Materials
URS-ID-100
 Stock Literature (literature for off-the-shelf components - motors,
relays, etc)
 Change Parts List
 Spare Parts List
 Lubricant List
 Operation and Maintenance Manual
 Alarm and Fault List
 Preventive Maintenance Schedule
 Trouble Shooting Guide
 Applicable MSDS’
Draft versions of the Manuals and drawings shall be provided four weeks
URS-ID-101
prior to Factory Acceptance Test (FAT).
Final versions of the Manuals and drawings shall be provided at the time
URS-ID-102 of FAT. Verification for accuracy will be conducted during FAT
execution and redlined corrections made as necessary.

PAGE Citra-Labs USER REQUIREMENTS SPECIFICATION

Braintree, MA 02184 REV REV DATE
18 of 19 www.Citra-Labs.com
B 02/18/2013 Batch Style Glass Washer URS-Glass Washer
CONFIDENTIAL. Property of Biomet/Citra Labs. Do Not Reproduce or Distribute Without the Prior Written Permission of Biomet/Citra Labs
 Citra-Labs
Braintree, MA
USER REQUIREMENTS SPECIFICATION

19.1. Documentation
ID Number Requirement Description
The supplier will provide installation instructions and drawings at the
time of FAT. This will include size, dimensions and pick up points of
URS-ID-103
crating. A review of the instructions/drawings will be made at FAT and
corrections made as necessary.

20. Equipment Testing Requirements

20.1. Equipment Testing

ID Number Requirement Description
A complete FAT will be performed at the supplier’s location. Testing will
include but is not limited to:
 Evaluation for URS compliance
 Drawing verification
 Documentation verification
URS-ID-104
 HMI Screen functionality
 I/O checkout
 Alarm/Fault verification
 Emergency stop verification
 Cycle verification
Supplier shall provide all utilities to allow the full production operation of
URS-ID-105
the equipment. Test water must be provided at 80°C.
The owner will provide components required for the FAT. The supplier
shall provide secure storage for these components and store the
URS-ID-106
components in accordance with owner’s instructions. These components
shall only be used by the supplier during FAT testing.

21. Attachments
01 – Exception List
02 – Bottle Drawings

PAGE Citra-Labs USER REQUIREMENTS SPECIFICATION

Braintree, MA 02184 REV REV DATE
19 of 19 www.Citra-Labs.com
B 02/18/2013 Batch Style Glass Washer URS-Glass Washer
CONFIDENTIAL. Property of Biomet/Citra Labs. Do Not Reproduce or Distribute Without the Prior Written Permission of Biomet/Citra Labs