SUB 00029-B03 v2.0

Cerus Corporation
INTERCEPT Blood System for Platelets

SN 065, Alternate Plastics
Device Design Dossier, Part B Section 3 - Drawings, Design and Product Specifications
TABLE OF CONTENTS
3 DRAWINGS, DESIGN AND PRODUCT SPECIFICATIONS ...........................3

3.1 Executive Summary of Product Design .........................................................3
3.2 Background and Description of Change ........................................................4
3.2.1 Plastics Materials Changes ....................................................................5
3.2.1.1 Design Changes ......................................................................9
3.3 Comprehensive Description of the INTERCEPT Blood System for
Platelets ...........................................................................................................12
3.3.1 INTERCEPT Processing Set for Platelets ...........................................12
3.3.1.1 INTERCEPT Processing Set for Platelets Key
Components .........................................................................................14
3.3.2 INTERCEPT Illuminator .....................................................................16
3.3.3 Mechanism of Action...........................................................................16
3.3.4 Platelet Processing Using the INTERCEPT Sets.................................17
3.4 INTERCEPT Processing Set for Platelets Product Components and
Materials .........................................................................................................18
3.4.1 Amotosalen Solution Subassembly (Wet Side) ...................................21
3.4.2 INTERCEPT Chain Subassembly (Dry Side) .....................................23
3.4.2.1 Illumination Container ..........................................................23
3.4.2.2 Compound Adsorption Device (CAD) Container.................24
3.4.2.3 Storage Container(s) .............................................................26
3.4.3 Label Material ......................................................................................27
3.4.4 Packaging Design.................................................................................27
3.5 Design Specification for the INTERCEPT Processing Set for Platelets ...28
3.6 Product Release Criteria for the INTERCEPT Processing Set for
Platelets ...........................................................................................................60
3.6.1 Labeling Verification ...........................................................................63
3.7 Representative Bill of Materials ...................................................................63
3.8 Referenced Documents ..................................................................................63
List of Tables
Table 3-1 Proposed Plastic Material Changes for the INTERCEPT Processing Set
for Platelets .....................................................................................................5
Table 3-2 Key Components of the INTERCEPT Platelets Processing Set ...................15
Table 3-3 Processing Range Requirements for INTERCEPT Processing Sets for
Platelets .........................................................................................................18
Table 3-4 INTERCEPT Processing Set for Platelets Components and Materials ........20
Table 3-5 INTERCEPT Processing Set for Platelets Design Specifications with
Alternate Plastics – Treated Platelets Performance Requirements ..............29
Alternate Plastics – Set Configuration Requirements ...................................38
SUB 00029-B03, v2.0 CONFIDENTIAL Page 1 of 63

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Alternate Plastics – Functional Requirements ..............................................45
Alternate Plastics – Interface and Safety Requirements ...............................57
Table 3-9 Certificate of Conformity Testing.................................................................60
Table 3-10 Final S-59 Analysis (pH) after Connection Testing .....................................61
Table 3-11 Final Chemical Analysis, Solution Amotosalen ...........................................61
Table 3-12 Bacteriology-Bioburden Testing ...................................................................62
Table 3-13 Final Physical Testing ...................................................................................62
List of Figures
Figure 3-1: INTERCEPT Platelet Processing Set with Alternate Plastic Materials –
Amotosalen Solution Container ......................................................................6
Platelet Storage Container, CAD Container and Illumination Container .......7
Container Ports, Tubing, Cannulas, PVC-Containing Components ...............7
CAD Wafer (Binder Only)..............................................................................8
Figure 3-5: INTERCEPT Processing Set Amotosalen Solution Container .......................9
Figure 3-6: INTERCEPT Processing Set Amotosalen Solution Container Air Pillow ...10
Figure 3-7: INTERCEPT Processing Set Tube Clamps ..................................................11
Figure 3-8: INTERCEPT Processing Set for Small Volume Platelet Units (SV) ...........13
Figure 3-9: INTERCEPT Processing Set for Large Volume Platelet Units (LV) ...........13
Figure 3-10: INTERCEPT Platelet Processing Set with Dual Storage Containers (DS) ..14
Figure 3-11: Pictorial View of the Mechanism of Action .................................................17
Figure 3-12: INTERCEPT Processing Set for Platelets (DS Depicted) made with
Alternate Plastics Components and Materials ..............................................19
Figure 3-13: Amotosalen Solution Container ....................................................................22
Figure 3-14: Illumination Container ..................................................................................23
Figure 3-15: Compound Adsorption Device (CAD) .........................................................25
Figure 3-16: Storage Container(s) .....................................................................................26

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3 DRAWINGS, DESIGN AND PRODUCT SPECIFICATIONS
3.1 Executive Summary of Product Design
The INTERCEPT Blood System is a Class III medical device intended for the preparation
and storage of pathogen inactivated platelets. The INTERCEPT Blood System consists of
INTERCEPT Processing Sets which include the synthetic psoralen, amotosalen, and the
INTERCEPT Illuminator, a UVA illumination device. The system was designed to be used
with donor-derived platelets collected using either pooled buffy coat or apheresis collection
methods and suspended in a mixture of platelet and additive solutions (InterSol™, SSP+,
T-PAS+, Grifols PAS-IIIM) or suspended in 100% plasma.
The INTERCEPT Platelet Processing Set is offered in four configurations:
• INTERCEPT Processing Set for Small Volume Platelet Units, INT21 (SV)
• INTERCEPT Processing Set for Large Volume Platelet Units, INT22 (LV)
• INTERCEPT Platelet Processing Set with Dual Storage Containers, INT25 (DS)
• INTERCEPT Platelet Processing Set with Triple Storage Containers, INT26 (TS)
Each INTERCEPT Platelet Processing Set consists of four integrated plastic disposable
containers:
• Amotosalen solution container
• Illumination container for the platelets during INTERCEPT treatment
• Compound Adsorption Device (CAD) container for the reduction of residual

amotosalen and free photoproducts
• Storage containers for platelet storage prior to transfusion
The system is used to inactive a broad spectrum of viruses, bacteria, and parasites as well
as contaminating donor leukocytes in platelet components. This process is intended to
reduce the risk of transfusion-associated transmission of viruses, bacteria, and parasites,
prevent transfusion-associated graft versus host disease, and may also reduce the risk of
other adverse effects due to contaminating donor leukocytes. Platelet components
processed using the INTERCEPT Blood System (“INTERCEPT Platelets”) are indicated
for transfusion support of patients requiring platelet transfusions according to clinical
practice guidelines. Any type of thrombocytopenia or qualitative platelet disorder resulting
from disease, therapy, or injury can be supported with INTERCEPT Platelets.
INTERCEPT treatment may be used as an alternative to gamma irradiation for prevention

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of transfusion-associated graft-versus-host disease (TA-GVHD). INTERCEPT treatment

may be used in place of CMV testing and leukoreduction for prevention of
transfusion-transmitted CMV infection. INTERCEPT Platelets are not clinically different
from untreated platelets and are infused according to standard platelet infusion methods.
The INTERCEPT Blood System for platelets was originally developed by Cerus
Corporation and Baxter Healthcare Corporation (Baxter). In 2006, Baxter returned
worldwide development and commercialization rights to Cerus (with the exception of
rights to Southeast Asian markets). In 2007, Baxter Healthcare sold its Transfusion
Therapies division to Fenwal, Inc. Fenwal continues to manufacture the INTERCEPT
Platelets Processing Sets under contract to Cerus. In 2010, Cerus gained the commercial
rights to Southeast Asian markets.
The INTERCEPT Blood System for platelets were designed and manufactured under the
Quality Systems specified in the Cerus, Fenwal, and Baxter Quality Manuals. The system
was designed such that, when it is used as intended, it provides a high level of protection of
health and safety. Since ownership of the INTERCEPT Blood System for platelets was
transferred to Cerus Corporation, Cerus maintains procedures that control and verify
product design to ensure that the essential requirements of the Medical Device Directive
(MDD) are met.
3.2 Background and Description of Change
As the INTERCEPT Blood System was originally developed in collaboration with Baxter,
most of the plastic sheeting, tubing and co-extruded ports used in the INTERCEPT
processing sets are currently sourced from Baxter. Cerus received notification that two of
the raw materials used in INTERCEPT Processing Sets, Baxter’s PL2410 and PL2411
plastic formulations, are being discontinued by the supplier. Therefore, Cerus initiated
work to qualify alternate plastics for use with INTERCEPT Processing Sets with the
following additional considerations:
• Though European Pharmacopoeia and MDD 93/42/EEC allows for DEHP to be

used as plasticizers in medical devices, this change minimizes use of non-DEHP
plastics whenever possible to reduce as far as possible the risks of DEHP
• Use of commercially available medical-grade plastics (versus custom-produced

plastics such as Baxter PL2410 and PL2411) sourced from suppliers with multiple
production locations for supply chain security and business continuity
Accordingly, Cerus is seeking TÜV approval for the use of alternate plastic materials for
the INTERCEPT Processing Sets for platelets, in addition to design changes and associated
manufacturing changes being made for product improvement. There is no change to the

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intended use of the INTERCEPT Blood System or INTERCEPT treatment process as a

result of this change. A summary of the alternate plastics and design changes is presented
in the following sections.
3.2.1 Plastics Materials Changes
Table 3-1 summarizes the proposed plastic materials changes for the INTERCEPT
Processing Set for platelets. The proposed EVA-blend and non-DEHP PVC plastics have
been used in the EU for CE Marked platelet storage sets and other blood contact products
and the proposed plastic for the amotosalen solution container is a polypropylene-based
plastic used for standard IV solutions. The proposed plastics have been qualified by the
suppliers in accordance with EP monographs for container materials and ISO 10993
standards. Most of the components in the sterile-fluid path of INTERCEPT Processing Set
are categorized as “limited contact duration” as the indirect blood component contact
during the INTERCEPT treatment process is transient for most components. Cerus has
qualified the INTERCEPT Processing Set plastic containers according to EP monographs
for containers, and relevant ISO 10993 and ISO 3826 standards (Design Dossier, Part B
Section 4.1). There is no change in container manufacturing suppliers. Fenwal, La Châtre,
France will continue to manufacture the amotosalen solution, illumination, CAD, and
platelet storage containers and test the INTERCEPT finished goods under contract to
Cerus.
Table 3-1 Proposed Plastic Material Changes for the INTERCEPT

Processing Set for Platelets
Current Uses of
Description Current Material Alternate Material
Alternate Materials
Amotosalen solution Polyolefin Polypropylene IV solution containers
container (Baxter PL2411) (Renolit Infuflex 7234)
See Figure 3-1
Platelet storage container, EVA blend EVA blend Fresenius Kabi platelet
CAD container and (Baxter PL2410) (Renolit Transfufol 8300) storage container
illumination container
See Figure 3-2
Container ports, tubing, Components with various Components with alternate Other IV and blood
cannulas, other PVC- DEHP PVC formulations plastics including: contact products
containing components (Baxter PL1813-1,
PL2410, PL2409, PL146, non-DEHP PVC
PL1230, PL795) Raumedic MED8036
Modenplast RB3 NDG
co-extruded
polypropylene and non-
DEHP PVC:
Renolit Tubeflex 9015
See Figure 3-3

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Current Uses of
Description Current Material Alternate Material
Alternate Materials
Binder materials for CAD EVA blend EVA blend plastic binder Same resin beads used to
wafer (60% binder: 40% (Baxter PL2410) (Renolit Solmed make the Renolit
adsorbent resin) Granuflex 8300) Transfufol 8300 sheeting
See Figure 3-4
Figure 3-1 INTERCEPT Platelet Processing Set with Alternate Plastic Materials –
Amotosalen Solution Container

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Platelet Storage Container, CAD Container and Illumination Container
Container Ports, Tubing, Cannulas, PVC-Containing Components

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CAD Wafer (Binder Only)

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3.2.1.1 Design Changes
3.2.1.1.1 Amotosalen Solution Container

Figure 3-5 depicts the proposed changes to the amotosalen solution container used in the
INTERCEPT Processing Set. The current amotosalen solution container includes a Baxter
PL 2411 container with integral Baxter PL 2420 red film and a labeled Baxter PL 2420 red
sleeve. The proposed amotosalen solution container includes the Renolit Infuflux 7234
container without integral Baxter PL 2420 red film but still maintains the labeled Baxter
PL 2420 red sleeve. Cerus has completed stability and photostability data for INTERCEPT
sets with the proposed amotosalen solution container design which demonstrate the integral
Baxter PL 2420 red film is not an essential design feature. This data is provided in Design
Dossier, Part B Section 5.
Figure 3-5 INTERCEPT Processing Set Amotosalen Solution Container

Current Proposed
Baxter PL 2411 container Renolit Infuflex 7234 container
a) with integral Baxter PL 2420 red film a) without integral Baxter PL 2420 red
and b) loose PL2420 red film film and b) with loose PL2420 film
a) b) a) b)
3.2.1.1.2 CAD Container for the Dual Storage Set

For the INTERCEPT Platelet Processing Set with Dual Storage Containers (DS Set), a
change to the CAD container volume from 1.0 L to 1.3 L is proposed for optimal
incubation conditions when processing higher platelet doses. The 1.3 L CAD container is
identical to the CAD container approved for INTERCEPT Platelet Processing Set with
Triple Storage Containers (TS Set) except that the CAD container for the TS Set contains
two wafers while the DS Set contains one wafer.

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3.2.1.1.3 Other Design Changes

Air Pillow
Figure 3-6 depicts the proposed change to the amotosalen solution container air pillow
used in the INTERCEPT Processing Set for Platelets. The current air pillow is
manufactured at Fenwal Maricao, Puerto Rico and connects to the amotosalen container via
a tube bushing. The proposed air pillow manufactured with alternate plastics will be
manufactured at Fenwal, La Châtre, France and will connect to the amotosalen solution
container without a tube bushing segment. Additional information on the manufacturing
transfer of the amotosalen solution container air pillow is provided in Design Dossier,
Part B Section 8, Manufacturing.
Figure 3-6 INTERCEPT Processing Set Amotosalen Solution Container Air Pillow
Tube Clamps
Figure 3-7 depicts the proposed change to the tube clamps used in the INTERCEPT
Processing Set for Platelets. The current SV/LV/DS Sets use slide tube clamps. The
approved TS Set and INTERCEPT Plasma Set use pinch tube clamps. This change is to
modify the SV/LV/DS Platelet Sets to pinch tube clamps so that all INTERCEPT product
configurations use the same tube clamp.

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Figure 3-7 INTERCEPT Processing Set Tube Clamps

Current Proposed
Slide Clamp Pinch Clamp
Baxter PL2528 Halkey Robert PL611
Cannula
The current INTERCEPT Processing Set contains two cannula designs, one for the
amotosalen solution container subassembly (wet-side) and one for the photochemical
treatment disposable subassembly (dry-side). The cannulas located on the top and bottom
of the amotosalen solution container (wet-side) consist of a polycarbonate frangible press
fit into a polyvinyl chloride housing. The cannula solvent bonded to the illumination
container and the tubing between the CAD container and in-line filter of the dry-side
consists of a polyvinyl chloride frangible sealed into a polyvinyl chloride housing. The
proposed INTERCEPT Processing Set with alternate plastics will contain a single cannula
design used on both the wet and dry-sides, and is identical to the existing wet-side cannula.

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3.3 Comprehensive Description of the INTERCEPT Blood System for Platelets
The INTERCEPT Blood System has been developed for the inactivation of pathogens and
leukocytes in platelets using the INTERCEPT Processing Set for platelets and the
INTERCEPT Illuminator.
3.3.1 INTERCEPT Processing Set for Platelets
The INTERCEPT Platelet Processing Set is offered in four configurations:
• INTERCEPT Processing Set for Small Volume Platelet Units, INT21 (SV)
• INTERCEPT Processing Set for Large Volume Platelet Units, INT22 (LV)
• INTERCEPT Platelet Processing Set with Dual Storage Containers, INT25 (DS)
• INTERCEPT Platelet Processing Set with Triple Storage Containers, INT26 (TS)
Each INTERCEPT Platelets Processing Set is provided as integral containers in a sealed

overwrap. Each set includes a 3 mM (SV, LV, DS) or 6 mM (TS) amotosalen solution in a
20 mL polypropylene plastic container, a 1.0 L (SV/LV/DS) or 1.3L (TS) EVA blend
plastic illumination container, a 1.0 L (SV, LV, DS with current plastics) or 1.3 L (DS with
alternate plastics, TS) EVA blend plastic Compound Adsorption Device (CAD) container
with one (SV, LV, DS) or two (TS) adsorbent wafers, and either one (SV/LV), two (DS) or
three (TS)1.3 L EVA blend plastic platelet storage container(s), all sequentially integrated.
Diagrams of the INTERCEPT Platelets Processing Set with alternate plastics in SV, LV
and DS configurations are provided below. The TS configuration with alternate plastics is
the same as the DS set, but differs in the concentration of the amotosalen solution, size of
the illumination container, two wafers in CAD container, and number of total storage
containers.

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Figure 3-8 INTERCEPT Processing Set for Small Volume Platelet Units (SV)
Figure 3-9 INTERCEPT Processing Set for Large Volume Platelet Units (LV)

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Figure 3-10 INTERCEPT Platelet Processing Set with Dual Storage Containers
(DS)
3.3.1.1 INTERCEPT Processing Set for Platelets Key Components
The INTERCEPT Processing Set for platelets consists of the amotosalen solution, the
illumination container, the CAD container and platelet storage containers. Manufacturing is
contracted to Fenwal (a Fresenius Kabi company), La Châtre, France. The key components
of the processing set are described in Table 3-2. Material descriptions for these
components are detailed in Section 3.4.

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Table 3-2 Key Components of the INTERCEPT Platelets Processing Set

Component Function Description
Sterile Fluid Path Device
Amotosalen Amotosalen Solution Amotosalen solution (3mM or 6mM) is provided as a sterile solution
Solution in a containing :
Polypropylene • 15.2 mg per 15 mL of 0.924% sodium chloride (Small Volume
Plastic Container Platelet Processing Set)
(Wet-Side)
• 17.7 mg per 17.5 mL of 0.924% sodium chloride (Large Volume
and Dual Storage Containers Platelet Processing Set)
• 30.5 mg per 15 mL of 0.924% sodium chloride (Triple Set
storage Containers Platelet Processing Set)
Amotosalen Solution The amotosalen solution container consists of a sealed 20mL
Container polypropylene or polyolefin container, wrapped in a loose PL 2420
sleeve. This container is compatible with amotosalen solution and
moist heat sterilization. The loose PL 2420 serves as a UVA light
barrier.
Note: The design with alternate plastics does not include the integral
PL 2420 red film present on current commercial configuration as
described in Section 3.2.2.1 above.
EVA Blend Plastic Illumination Container Illumination container, a 1.0L (SV/LV/DS) or 1.3L (TS) container
Containers comprised of a monolayer extruded film composed of primarily
(Dry-Side) ethylene vinyl acetate (EVA); compatible with sterilization by
radiation, UVA illumination and storage of INTERCEPT platelets.
CAD (Compound The CAD wafer is a porous wafer media composed of spherical
Adsorption Device) adsorbent beads suspended in a binder matrix in a mesh pouch. The
Container ratio of adsorbent bead to EVA blend binder is 40%/60% by weight.
The CAD in the mesh pouch and EVA blend container are
compatible with sterilization by radiation and storage of
INTERCEPT platelets.
There are 2 CAD wafers in the TS set in 1.3L, while the other
configurations have only 1 CAD wafer in either 1.0L (SV, LV) or
1.3L (DS).
Storage Container Storage containers, 1.3L, a monolayer extruded film composed of
primarily ethylene vinyl acetate (EVA), compatible with sterilization
by radiation and storage of INTERCEPT platelets.
Packaging
Polyethylene Two- Secondary unit packaging Each INTERCEPT Processing Set is packaged in a perforated
Compartment polyethylene pouch. There is no change to this material.
Pouch
Aluminum Foil Water vapor barrier, light Coextruded laminated aluminum foil
Overpouch protection, and gas / (polyester/aluminum/polyethylene). There is no change to this
vapor barrier material.
Carton Shipping Carton Corrugated carton. There is no change to this material.

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3.3.2 INTERCEPT Illuminator
The INTERCEPT Illuminator is an accessory that delivers a controlled amount of UVA

light (wavelength 320 to 400 nm) to the illumination container using an arrangement of
lamps, filters, and intensity monitoring photodiodes. This accessory instrument is a Class I
device (with no measuring function) subject to rules 1 and 12 of Annex IX of the Medical
Device Directive 93/42/EEC. Manufacturing is contracted to Nova Biomedical.
The system has the capability of illuminating the illumination containers from 2 disposable
sets per processing cycle. Each platelet container rests on a UVA transparent tray that
undergoes reciprocal shaking using an internal shaker during the illumination process. The
illumination compartments consist of 2 opposing banks of UVA fluorescent lamps
mounted above and below the illumination tray. The UVA dose to the compartment is
monitored by photodiodes that integrate the UVA dose. The instrument is designed to
provide proper light exposure during illumination. The intensity and duration of the light
dose required for INTERCEPT treatment is monitored by photodiode sensors within the
INTERCEPT Illuminator. During device operation, the software monitors the amount of
light energy delivered to the blood product in the illumination container. The operator uses
a graphical user interface (GUI), which includes a color display screen and keypad. The
operation of the device is menu driven by a selection of options and data input from a
barcode scanner or the keypad. The INTERCEPT treatment records are maintained on the
illuminator and may be printed or transferred to a server.
The Illuminator function and dose settings used for the INTERCEPT Platelet SV, LV, DS
and TS processing sets will not change with the change to the alternate plastics. The
Illuminator will be used in the testing of the alternate plastics materials which will allow
Cerus to confirm its performance. Additional information on the INTERCEPT Illuminator
is provided in Design Dossier, Part B Section 12.
3.3.3 Mechanism of Action
The INTERCEPT treatment process for platelets is performed at blood processing centers.
The INTERCEPT Blood System for Platelets is an ex vivo process for the preparation and
storage of pathogen-inactivated platelets for therapeutic use. The system uses the synthetic
psoralen, amotosalen (also referred to as S-59), and an illumination device to
photochemically treat platelet concentrates. The mechanism of action is based on targeting
nucleic acid (DNA and RNA) with formation of irreversible adducts to inhibit nucleic acid
replication. Platelets collected by apheresis or buffy coat preparation are connected to the
processing set using a sterile connection device. Platelets suspended in plasma with or
without additive solutions can be processed with this system. When using platelet additive
solutions, the plasma-to-platelet additive solution ratio in the suspension medium needs to
be approximately 35%/65%. Platelet products within the following ranges have been

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shown to be acceptable for use with the INTERCEPT platelet processing set: 53% to 68%
platelet additive solution and 32% to 47% plasma. Platelets flow through the amotosalen
container into the illumination container. The platelet/amotosalen mixture is illuminated
with UVA light provided by the INTERCEPT Illuminator, a Class I non-invasive medical
device that is used as an accessory component of the INTERCEPT Blood System. After
illumination, the concentration of residual amotosalen and free photoproducts formed are
reduced by adsorption in the CAD container and, finally, the platelet concentrate is
transferred to the storage container(s).
Figure 3-11 Pictorial View of the Mechanism of Action
3.3.4 Platelet Processing Using the INTERCEPT Sets
The processing requirements for the INTERCEPT Platelet Processing Set with alternate
plastics are the same as currently approved INTERCEPT Processing Sets for platelets. The
processing range requirements for each INTERCEPT processing set for platelets are shown
in the following table. Design Dossier, Part B Section 4.4 provides verification data for
the intended use which is INTERCEPT treatment of platelets intended for transfusion.

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Table 3-3 Processing Range Requirements for INTERCEPT Processing Sets for
Platelets
Small Volume Large Volume Large Volume Dual Storage Dual Storage Triple Storage
Parameter (SV) Set (LV) Set (LV) Set (DS) Set (DS) Set (TS) Set
(units)
INT21 INT22 INT22 INT25 INT25 INT26
Platelet Apheresis or Apheresis or Apheresis or Apheresis or Apheresis or Apheresis or
Source Whole Blood Whole Blood Whole Blood Whole Blood Whole Blood Whole Blood
PAS (53-
PAS (53-68%) PAS (53-68%) PAS (53-68%)
Suspension 68%) and
and plasma 100% plasma and plasma 100% plasma and plasma
Medium plasma
(32-47%) (32-47%) (32-47%)
(32-47%)
Volume (mL) 255 - 325 mL 300 - 420 mL 255 - 420 mL 300 - 420 mL 300 - 420 mL 420 – 650 mL
Platelet Dose 2.5 - 6.0×1011 2.0 - 7.0×1011 2.5 - 5.2×1011** 2.5 - 8.0×1011 2.5 - 8.0×1011 5.0 – 12.0 ×1011
RBC <4×106/mL <4×106/mL <4×106/mL <4×106/mL <4×106/mL <4×106/mL
CAD Time
4 - 16 6 - 16 16 - 24 6 – 16 16 - 24 4-16
(hrs)
**This change to platelet dose for INT22 is currently under review (TUV Confirmation No. 713106618
submitted on 15 May 2017)
3.4 INTERCEPT Processing Set for Platelets Product Components and Materials
This dossier section describes the individual components and materials comprising the
INTERCEPT Processing Sets for platelets. The following sections describe both the
current and alternate plastic materials used by product component. Additional information
by container is provided as follows:
Section 3.4.1, Amotosalen Solution Subassembly (Wet-Side)
Section 3.4.2, Photochemical Treatment Disposable Subassembly (Dry-Side)
Section 3.4.2.1, Illumination Container
Section 3.4.2.2, CAD Container
Section 3.4.2.3, Storage Container
Section 3.4.3, Label Material
Section 3.4.4, Packaging Design
The individual components and materials used are the same across SV, LV, DS and TS
product configurations. Figure 3-12 provides a representative product illustration of the
DS Set. The numeric codes in this figure correspond to item descriptions in Table 3-4.

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Figure 3-12 INTERCEPT Processing Set for Platelets (DS Depicted) made with Alternate Plastics Components and Materials

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Table 3-4 INTERCEPT Processing Set for Platelets Components and Materials
Item Material
Description
No. Current Alternate
Baxter PL 1813-1 pillow
with Baxter PL146 Raumedic MED8036 pillow
connection tubing (wet-side with Raumedic MED8036
1 Air Pillow Subassembly
and dry-side) and Baxter connection tubing and no
PL1813-1 bushing bushing
(wet-side only)
Baxter PL 146 (wet-side)
2 Tubing Raumedic MED8036
Baxter PL 1813-1 (dry-side)
Housing: Baxter PL 146
Housing: Modenplast RB3
(wet-side),
NDG
Baxter PL1813-1 (dry-side)
Frangible: Lexan 121R
Frangible: Same as current
3 Cannula/Housing Assembly (wet-side), Baxter PL1230
wet-side
(dry-side)
Bushing: Baxter PL146
Bushing: Raumedic
(wet-side),
MED8036
Baxter PL1813-1 (dry-side)
4 Container Port Baxter PL 2409 Renolit Tubeflex 9015
5 Amotosalen Container (20mL) Baxter PL 2411(film) Renolit Infuflex 7234 (film)
6 Bag Label - Amotosalen Container Teslin Same as current

7 UVA Barrier Film Baxter PL 2420 Same as current
Coextruded Baxter PL1813 Coextruded
(inside) Raumedic MED8036
8 Container Port, Small
and Baxter PL2410 (inside) and Raumedic
(outside) PE770 (outside)
Coextruded Baxter
9 Container Port, Large PL1813-1 (inside) and Same as current
Baxter PL2410 (outside)
10 Illumination Container, 1.0L or 1.3L Baxter PL 2410 Renolit Transfufol 8300
CAD Container, 1.0L or 1.3L with
11 Baxter PL 2410 Renolit Transfufol 8300
CAD Assembly
Adsorbent Beads: Purolite Adsorbent Beads: Same as
MN200 current
Binder: Baxter PL2410 or
12 CAD Assembly (wafer + mesh pouch) Binder: Baxter PL2410 Renolit Solmed Granuflex
8300
Mesh: Baxter PL3306
Mesh: Same as current
Saatifil PES 35/11M
Film stock/port: Baxter PL Film stock/port: Same as
13 In-Line Filter 1813-1 current
Mesh: Baxter PL3306 Mesh: Same as current
SV/LV/DS: Baxter PL 2528 SV/LV/DS: PL 611 (Pinch
14 Tube Clamp(s) (Slide clamps) clamps)
TS: PL611 (Pinch clamps) TS: Same as current
2-way: Baxter PL 1813-1 2-way: Modenplast RB3
15 Y-adapter NDG
3-way: Comef PVC 3-way: Same as Current

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Item Material
Description
No. Current Alternate
16 Storage Container Baxter PL 2410 Renolit Transfufol 8300
Hermetically Sealed Closure with Baxter PL1813-1 Same as current
17
Twist-Off Spike Port
18 Storage Container Label Teslin Same as current
3.4.1 Amotosalen Solution Subassembly (Wet Side)
The amotosalen solution container is manufactured from:
• (Current) Baxter PL 2411 plastic flexible film, a monolayer extruded polyolefin and
an integral PL 2420 polypropylene film; or
• (Alternate) Renolit Infuflex 7234 plastic flexible film, a multi-layer extruded

polypropylene film, without an integral layer of PL 2420 polypropylene film
The amotosalen solution container is a 20 mL container with a two ports (top and bottom)
design containing 15 mL or 17.5 mL of 3 mM amotosalen solution (SV, LV, DS) or 15 mL
of 6 mM amotosalen solution (TS). Each top and bottom port of the amotosalen solution
container is solvent bonded to a bushing and a cannula. The amotosalen solution container
is placed inside a loose Baxter PL 2420 red sleeve which is labeled with a Teslin (polymer)
self-adhesive label. The loose Baxter PL 2420 red sleeve protects the solution from
exposure to UVA light and is designed to fully cover the container as well as the portion of
the cannula at each end of the bag into which the solution can enter.
Figure 3-13 shows the 20 mL polypropylene amotosalen solution container with loose
PL 2420 sleeve and two polycarbonate breakaway cannulas.

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Figure 3-13 Amotosalen Solution Container
Polyolefin or Polypropylene Container with Loose Baxter PL 2420 Sleeve, Polycarbonate

Frangible with PVC Molded Cannula Housing for Amotosalen Solution – Sub-Assembly
The amotosalen container plastic sheeting is comprised primarily of polypropylene or

polyolefin, and is a modification of the European Pharmacopoeia (EP) monograph for 3.1.3
(polyolefin) and 3.1.6 (polypropylene). These plastic containers conform to the European
Pharmacopoeia monographs 3.2.2.1 and the film has been qualified for blood, blood
component, and aqueous fluid path applications sterilized by moist heat.
The container sheeting is sealed to co-extruded plastic ports. The inlet and outlet ports are
either polyolefin/polyester/polyvinylchloride (outer layer/tie layer/inner layer) co-extruded
material with the polyvinyl chloride layer as solution contact (Current) or
polypropylene/polyvinylchloride (outer layer/inner layer) co-extruded material with
polyvinyl chloride layer as solution contact (Alternate).
The amotosalen container ports are each solvent bonded to a polyvinyl chloride bushing.
The polyvinyl chloride bushings are each solvent bonded to cannulas consisting of a
polycarbonate frangible which is press fit into a polyvinyl chloride molded housing. Each
cannula is solvent bonded to polyvinyl chloride tubing containing a sealed polyvinyl
chloride air pillow.

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3.4.2 INTERCEPT Chain Subassembly (Dry Side)
3.4.2.1 Illumination Container
The Illumination Container is a sterile, UVA-transparent plastic container designed for the
mixing of amotosalen solution with platelets and to allow for ultraviolet light illumination
of the amotosalen/platelet mixture (Figure 3-14). The illumination container is filled with
the amotosalen solution and platelet mixture. The filled container is then illuminated by the
INTERCEPT Illuminator. Following illumination, the INTERCEPT platelets is transferred
through the CAD container and into the storage containers.
Figure 3-14 Illumination Container
EVA Blend Plastic Illumination Container for UVA illumination of platelet/amotosalen

mixture, with polycarbonate cannula
The illumination container is manufactured from flexible plastic film (Baxter PL 2410
(Current) or Renolit Transfufol 8300 (Alternate), both composed of an EVA blend. The
illumination container plastic sheeting is a modification of the EP monograph for EVA
(3.1.7). This plastic container conforms to the EP monograph 3.2.4 for containers and
ISO 3826-1. The film is qualified for blood, blood component and aqueous fluid path
applications sterilized by gamma irradiation.

Cerus Corporation
The illumination container is designed as a 1.0 or 1.3 liter, two-port (one small, one large),
top-sealed container. The tubing (both Current and Alternate) which connects the
amotosalen container to the Illumination container is made of polyvinyl chloride material
compatible with irradiation that is solvent bonded to a co-extruded plastic port using
cyclohexanone. There are two ports on the Illumination container, the inlet (small) port and
the outlet (large) port. The small inlet port is ethyl-vinyl acetate/ polyvinylchloride (outer
layer /inner layer) co-extruded material with the polyvinyl chloride layer as solution
contact.
The large outlet port of both the Current and Alternate illumination containers is an
ethyl-vinyl acetate/polyvinylchloride (outer layer/inner layer) co-extruded material with the
polyvinyl chloride layer as solution contact.
The outlet port of the illumination container is solvent bonded to a polyvinyl chloride
bushing. The illumination container bushing is also solvent bonded to a cannula which
consists of a polycarbonate frangible which is press fit in to a polyvinyl chloride molded
housing.
There is no label on the illumination container in order to not impede UVA light
transmission.
3.4.2.2 Compound Adsorption Device (CAD) Container
The CAD container provides a sterile vessel and contains adsorbent material for the
reduction of residual amotosalen and photoproducts following UVA light illumination of
the amotosalen solution and platelet mixture (Figure 3-15).
The CAD wafer is a 5.22” × 2.95” × 0.13” (nominal) porous wafer media composed of
spherical adsorbent beads suspended in an EVA blend binder matrix in a mesh pouch. The
ratio of adsorbent bead to binder is 40%/60%. There is 1 CAD wafer in the SV/LV/DS sets
and 2 CAD wafers in the TS set.
The CAD container is designed with a 1.0 liter or 1.3 liter, two-port, top-sealed container.
The inlet and outlet tubings are solvent bonded using cyclohexanone to the port bushings.
The CAD container is manufactured from flexible plastic film (Baxter PL2410 (Current) or
Renolit Transfufol 8300 (Alternate)), a monolayer EVA blend plastic film. The inlet and
outlet tubings are a polyvinyl chloride material compatible with irradiation that is solvent
bonded to a co-extruded plastic port using cyclohexanone.
Both ports of the CAD container are currently made from an ethyl-vinyl
acetate/polyvinylchloride (outer layer/inner layer) co-extruded material with the polyvinyl
chloride layer as solution contact.

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The inlet port of the CAD container is solvent bonded to polyvinyl chloride tubing. The
outlet port is solvent bonded to polyvinyl chloride tubing which is also solvent bonded to a
cannula. The cannula consists of a polycarbonate frangible which is press fit into a
polyvinyl chloride molded housing.
An in-line filter is also located in the tubing between the CAD container and the storage
and container(s). The in-line filter housing is manufactured from the same material as the
current plastic tubing. There is a single layer of medical grade polyester mesh sealed in the
filter housing and separating the two sides. The purpose of the in line filter is to act as a
secondary or redundant protection against adsorbent bead and bead fragments entering the
final storage container assemblies if a rupture in the polyester mesh covering the CAD
occurred.
Figure 3-15 Compound Adsorption Device (CAD) Container
CAD and EVA Blend Plastic Container for reduction of amotosalen and its free
photoproducts in INTERCEPT Treated Platelets

Cerus Corporation
The CAD is a sintered wafer consisting of two components sealed in a mesh pouch. The
components are an adsorbent bead of polystyrene and divinyl benzene copolymer
immobilized in a matrix of EVA blend binder. The mesh pouch is a medical grade
polyester mesh manufactured with 35 micron openings. The immobilized beads retain their
porous micro and macrostructure for the removal of amotosalen residual material and free
photoproducts in INTERCEPT platelets.
3.4.2.3 Storage Container(s)
The storage and transfusion containers are transparent sterile containers for storage and
transfusion of INTERCEPT platelets. A representation of the container is provided in
Figure 3-16.
Figure 3-16 Storage Container(s)
EVA Blend Plastic Storage Container(s)
The platelet storage/transfusion container design is a 1.3 liter, four-port (two small, two
large), top-sealed container. The inlet tubing used for connection to the storage container
contains a tube clamp and is solvent bonded to a small port using cyclohexanone. The other
small port is solvent bonded to polyvinyl chloride tubing containing a tube clamp and a

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polyvinyl chloride air pillow on one end. The large ports are solvent bonded to Twist-Off
Protectors, which provides a sterility barrier for transfusion. The container(s) are labeled
with a Teslin (polymer) self-adhesive label.
The small port is an ethyl-vinyl acetate/polyvinylchloride (outer layer/inner layer)

co-extruded material with the polyvinyl chloride layer as solution contact. The large port is
an ethyl-vinyl acetate/polyvinylchloride (outer layer/inner layer) co-extruded material with
the polyvinyl chloride layer as solution contact.
The platelet storage and transfusion containers are manufactured from flexible plastic film
(Baxter PL2410 (Current) or Renolit Transfufol 8300 (Alternate)), a monolayer EVA blend
plastic film. The container has an extended flap, identity marking and “INTERCEPT Blood
System” embossed logo.
The storage container plastic sheeting is a modification of the EP monograph for EVA
(3.1.7). PL 2410 plastic containers conform to the EP monograph 3.2.4 for containers and
ISO 3826-1. The film is qualified for blood, blood component and aqueous fluid path
applications sterilized by gamma irradiation.
3.4.3 Label Material
The label used on the plastic containers is self-adhesive and comprised of a microporous
plastic. The plastic is a homogenous blend of polyolefins and inert fillers and coated with a
solvent base adhesive. The label is qualified for use on plastic containers with blood, blood
component and aqueous applications sterilized by gamma irradiation and moist heat. There
is no change to the label material with this change notification.
3.4.4 Packaging Design
There is no change to packaging design with this change notification. The INTERCEPT
Platelets Processing Set design consists of an amotosalen container assembly (wet
subassembly, sterilized by moist heat) and an INTERCEPT chain (dry subassembly
consisting of the illumination container, CAD container and storage container(s), sterilized
by irradiation), which are connected and sterilized by e-beam irradiation to make a
complete set.
Prior to being placed into a two-compartment polyethylene pouch, the INTERCEPT chain
is folded into and around a polyethylene card (organizer). The organizer functions as a way
to protect the bags from creasing, tubing from getting kinked, and orients the INTERCEPT
chain so that it can properly fit into the UVA device tray. An ethylene propylene diene
monomer (EDPM) band is used to hold the CAD container and storage containers to the
inside and outside of the organizer to keep the set from coming unpackaged) during
processing.

Cerus Corporation
The INTERCEPT chain (dry-side) is packaged in a two-compartment poly pouch prior to

sterilization by gamma irradiation. The INTERCEPT chain (folded in and around the
organizer) is placed into the larger compartment of the two-compartment pouch. The pouch
also minimizes direct handling of the INTERCEPT chain prior to the e-beam process. Once
the e-beam operation has been completed the amotosalen container subassembly (wet-side)
is placed into the smaller compartment of the two-compartment pouch. The process is
designed to help limit bioburden in preparation for the final ozone treatment of the
completed assembly. After the e-beam connection, to combine the sterilized wet and dry
subassemblies, the two-compartment pouch is sealed for tamper evidence.
Six two-compartment pouches are packaged together into a foil overwrap and subjected to
ozone treatment, after which the foil overwrap is sealed. The foil overwrap functions as a
moisture and vapor barrier. Four foil overwraps are then placed into the final corrugated
shipping carton for a total pack factor of 24 units.
3.5 Design Specification for the INTERCEPT Processing Set for Platelets
The INTERCEPT Processing Set for platelets is designed for the preparation and storage of
pathogen-inactivated platelets for therapeutic use when used with an illumination device to
photochemically treat platelet concentrates. To confirm the change to alternate plastics and
design changes did not impact the functional, performance and safety requirements of the
device, the following design and development requirements were validated or verified to
confirm the proposed design continues to meet product acceptance criteria.

Cerus Corporation
Table 3-5 INTERCEPT Processing Set for Platelets Design Specifications with Alternate Plastics –
Treated Platelets Performance Requirements
Requirements Definition
Justification or Design Dossier
Item Product Attribute Minimum Requirement Rationale Reference Supportive Data
TREATED PLATELETS PERFORMANCE REQUIREMENTS
1 Clinical Performance Transfusion of INTERCEPT Blood System for platelets is comparable to Safety and Efficacy Part B, Section Clinical
conventional platelets in terms of overall efficacy and safety in patients 6.0 Evaluation Report
DES-TPP 00258 -
R009
DES-TPP 00168

Cerus Corporation
2 Pathogen Reduction / Treatment with the INTERCEPT Blood System for platelets shall result in a DES-TPP 00258 – Part B, Section EU Technical
Inactivation biologically equivalent pathogen reduction to that found in the current R010 and R011 4.4 Data Sheet:
approved EU Technical Data Sheet for clinically relevant pathogens,
DES-TPP 00168 Part B, Section PRD-TDS 00121
including:
5.0
• a broad spectrum of gram-positive and gram-negative bacteria, enveloped Platelets in PAS:
and non-enveloped viruses frequently implicated in transfusion DEL 00490
transmitted infections,
DEL 00491
• emerging pathogens such as those that cause malaria, dengue,
chikungunya for which there are no commercially available tests, DEL 00496
• established threats such as HIV-1, HBV and HCV DEL 00497
• leucocytes DES-RD-DIOM
The technical data sheet for each geography will define the pathogen 00222
reduction/inactivation claims approved by the responsible regulatory agency.
Platelets in 100%
Relevant model organisms may be utilized where accepted/recognized by the
Plasma:
responsible regulatory agency.
DEL 00488
DEL 00489
DEL 00494
DEL 00495

Cerus Corporation
3 In-vitro Platelet Platelets treated with INTERCEPT Blood System have the following in-vitro Directive 2004/33/EC Part B Section 4.4 Platelets in PAS:
Function function:
DES-TPP 00258 - Part B Section 5.0 PRD 00330
PLATELETS IN PAS AND 100% PLASMA: R013
o
pH (22 C) >6.4 at the end of storage DEL 00499
DES-TPP 00168
DEL 00501
REL 00502
DES-RD-DIOM
00222
Platelets in 100%
Plasma:
DEL 00514
DEL 00515
VAL 00365

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4 Transfusable Dose >75% of the transfusable units contain ≥2×1011 post-INTERCEPT treatment EDQM 18th Ed. Part B Section 4.4 Platelets in PAS:
DES-TPP 00258 - Part B Section 5.0 PRD 00330
R014
DEL 00499
DES-TPP 00168
DEL 00501
REL 00502
DES-RD-DIOM
00222
Platelets in 100%
Plasma:
DEL 00514
DEL 00515
VAL 00365

Cerus Corporation
5 Shelf Life Platelets treated with INTERCEPT Blood System have 7 days of shelf life in DES-TPP 00258- Part B, Section Platelets in PAS:
EU. R013 4.4
PRD 00330
Local health authority approvals for platelet shelf life may be less than 7 days. 2004/33/EC Part B, Section
DEL 00499
5.0
DES-TPP 00168
DEL 00501
REL 00502
DES-RD-DIOM
00222
Platelets in 100%
Plasma:
DEL 00514
DEL 00515
VAL 00365

Cerus Corporation
6 Platelet Dose Loss Platelets treated with INTERCEPT Blood System result in a mean platelet DES-TPP-00258 – Part B Section 4.4 Platelets in PAS:
dose loss ≤14% post-INTERCEPT treatment R018
Part B Section 5.0 PRD 00330-2
DES-TPP 00168
DEL 00499
DEL 00501
REL 00502
DES-RD-DIOM
00222
Platelets in 100%
Plasma:
DEL 00514
DEL 00515
VAL 00365

Cerus Corporation
7 Platelet Volume Loss PLATELETS IN ADDITIVE SOLUTION: Marketability Part B, Section Platelets in PAS:
4.4
Platelets treated with INTERCEPT Blood System result in a mean platelet DES-TPP 00258- PRD 00330
volume loss <14% post-INTERCEPT treatment RO18 Part B, Section
DEL 00499
5.0
PLATELETS IN 100% PLASMA: DES-TPP 00168
DEL 00501
Platelets treated with INTERCEPT Blood System result in a mean platelet
REL 00502
volume loss <14% post-INTERCEPT treatment
DES-RD-DIOM
00222
Platelets in 100%
Plasma:
DEL 00514
DEL 00515
VAL 00365

Cerus Corporation
8 Patient Safety Platelets treated with INTERCEPT Blood System are acceptable for clinical Safety, Regulatory Part B Section 6.0 Clinical
evaluation in humans Requirement for Evaluation Report
testing in humans and
Patient safety shall be supported by a comprehensive toxicology program and ICH guidelines
bioanalytical characterization of treated blood components (S-59 and DES-TPP 00258 –
photoproducts by HPLC) R009
DES-TPP 00168
Bioanalytical
characterization of S-
59 and photoproducts
in blood components
is required to justify
no new toxicology
studies required for
design changes

Cerus Corporation
9 Clinical Safety Platelets treated with INTERCEPT Blood System are safe and tolerable for Safety, Clinical study Part B Section 6.0 Clinical
further clinical evaluation in humans in healthy subjects to Evaluation Report
assess the safety and
tolerability of
transfusion of IBS
platelets. Evaluate
pharmacokinetics,
platelets clearance,
and effect on
coagulation factors
compared to standard
untreated platelets.
10 Post-Marketing Safety Transfusion of platelets treated with INTERCEPT Blood System for platelets Safety, hemovigilance Part B Section 6.0 Clinical
from countries is safe when transfused to patients in routine therapeutic use. study or program to Evaluation Report
safety data in patients
requiring transfusion
of platelets.

Cerus Corporation
Table 3-6 INTERCEPT Processing Set for Platelets Design Specifications with Alternate Plastics – Set Configuration Requirements
Design Dossier
Item Product Attribute Minimum Requirement Justification or Rationale Reference Supportive Data
SET CONFIGURATION REQUIREMENTS
11 Integrated Processing • Integrated processing set (i.e., wet side and dry side are connected at DES-TPP 00258-R001 Part B, Section SPC 00342
Set time of manufacture of the disposable processing set) such that 3.7
DES-TPP 00258-R002 SPC 00642-1
customer is not required to perform additional sterile connections other
than attaching platelet donation unit. DES-TPP 00258-R003 SPC 00643-1
• The Processing Set shall contain an integrated sterile fluid path. DES-TPP 00258-R023 SPC 00644-1
• The Processing Set design shall incorporate: DES-TPP 00258 – R026 SPC 00645-1
• The treatment chemical (amotosalen solution) in a container with a UV (hanging length) SPC 00646
protective barrier DES-TPP 00168
• An illumination container
• A compound adsorption device (CAD) and in-line filter
• A single platelet storage container for SV/LV configurations
• Two platelet storage containers for the DS configuration
• Three platelet storage containers for TS configuration
• The length from the amotosalen container air pillow to the bottom of
the bundled CAD container/platelet storage container(s) shall not
exceed 60”
• The length from the illumination container to the bottom of the platelet
storage container(s) shall not exceed 60”

Cerus Corporation
Design Dossier
12 Amotosalen Container The Amotosalen Container Subassembly design shall incorporate the Functional requirements Part B, Section SPC 00342
following: 3.7
SPC 00642-3
• Container has a capacity of 20 mL
SPC 00643-3
• Includes an inlet and outlet port to facilitate flushing of the contents
• Includes a UV barrier SPC 00644-3
• Contains a label SPC 00645-3
SPC 00646
13 Amotosalen Container The amotosalen container will be filled with the follow volume and System Requirement Part B, Section SPC 00107
Fill and Dose dose: 3.7
Design and Manufacturing SPC 00342
3 mM AMOTOSALEN SOLUTION: Requirement Part B, Section
SV SPC 00468
5.0
Fill Volume (mL): 14.70 to 15.30 SPC 00642
Amotosalen Dose (mg): 14.11 to 16.21 Part B, Section
LV/DS 8.0 SPC 00643
Fill Volume (mL): 17.15 to 17.85 SPC 00644
Amotosalen Dose (mg): 16.46 to 18.92
SPC 00645
6 mM AMOTOSALEN SOLUTION:
TS SPC 00646
Fill Volume (mL): 14.70 to 15.30 FC-VAL-16-151
Amotosalen Dose (mg): 28.3 to 32.6 (PQ lot release
testing)

Cerus Corporation
Design Dossier
14 Illumination Container The Illumination Container design shall incorporate the following: Functional, Performance, Part B, Section SPC 00342
Interface 3.7
• Container has a capacity of 1.0 L for SV/LV/DS and 1.3L for TS SPC 00642-2
configurations
SPC 00643-2
• Contains two ports, an inlet and outlet port
SPC 00644-2
• Shall have an extended flap of sufficient size to provide space for over-
labeling (i.e., donor ID labeling). The flap shall not cover any portion SPC 00645-2
of the illumination container once installed into the INT100
SPC 00646
illumination tray
• Is sized to fit in illumination tray of INT100 illuminator (11.17” x
7.67” or less)
• Has the numeral “1” and barcode locator symbol
• Container design includes a hanger hole
15 CAD Container The CAD container design shall incorporate the following: Design, Safety and product Part B, Section SPC 00342
• Container has a capacity of 1.0 L for SV/LV and 1.3 L for DS/TS performance 3.7
SPC 00562
• The CAD assembly shall contain a single adsorbent wafer enclosed in a SPC 00628
mesh pouch for SV/LV/DS and dual adsorbent wafers enclosed in a
mesh pouch for the TS configuration SPC 00642-2
• Container design includes a hanger hole SPC 00643-2
• Container includes two ports, an inlet and an outlet port SPC 00644-2
• Container includes a number identifier “2”
SPC 00645-2
• Container includes two holes which snap into the non-UVA illuminated
side of the Illuminator for DS/TS configurations SPC 00646
SPC 00092

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Design Dossier
16 Platelets Storage The Platelet Storage Container design shall incorporate the following: Functional; Ease of use; Part B, Section SPC 00342
Container • Container has a capacity of 1.3 L for SV/LV/DS/TS consistent with current 3.7
SPC 00642-2
practices at blood centers
• Contains a label SPC 00643-2
DES-TPP 00258 – R029-
• Container design includes a hanger hole
31 SPC 00644-2
• Contains two tamper-evident spike ports, one port with sampling
pouch, and one inlet tubing port DES-TPP 00168 SPC 00645-2
• Container includes a number identifier “3” SPC 00646
• Container includes two holes which snap into the non-UVA illuminated
side of the Illuminator
17 In-line Filter The in-line filter design shall incorporate the following: Design, Safety and product Part B, Section SPC 00342
• Contains a mesh layer to filter particulate matter from the CAD wafer performance 3.7
SPC 00642-2
• Contains an inlet and outlet port SPC 00643-2
SPC 00644-2
SPC 00645-2
SPC 00646

Cerus Corporation
Design Dossier
18 Tubing The tubing design shall incorporate the following: Design and Customer Part B, Section PRD 00325
• Compatible with approved sterile connection devices and tube sealers Requirements 3.7
PRD 00348
• Allows for flow between containers DES-TPP 00258 – R024
SPC 00342
DES-TPP 00168
SPC 00642-2&-3
SPC 00643-2&-3
SPC 00644-2&-3
SPC 00645-2&-3
SPC 00646
19 Cannula The cannula design shall incorporate the following: Design and Customer Part B, Section SPC 00342
• Unbroken cannulas shall prevent fluid flow Requirements 3.7
SPC 00642-2&-3
• Mechanical assistance shall not be required to break cannulas DES-TPP 00258 R019
SPC 00643-2&-3
(Human Factors)
• Cannulas shall allow for bi-directional flow once broken
SPC 00644-2&-3
• Cannulas located on the top and bottom of the amotosalen container DES-TPP 00168
SPC 00645-2&-3
• Cannula located between the Illumination container and the CAD
container SPC 00646
• Cannula located between the CAD container and the platelet storage
container

Cerus Corporation
Design Dossier
20 Split-Y junction • Shall contain a 2-way junction for DS Functional requirement Part B, Section SPC 00342
3.7
• Shall contain a 3-way junction for TS DES-TPP 00258 R028 SPC 00644-2
• Y-Junction shall allow for bi-directional flow (Fluid equalization)
SPC 00645-2
SPC 00646
21 Tubing Clamps The tubing clamp design shall incorporate the following: Functional, Ease of Use Part B, Section SPC 00342
• Occluded tubing clamps shall prevent fluid flow 3.7
SPC 00642-2
• Tubing clamp located on each tubing segment connected directly to the SPC 00643-2
inlet of the platelet storage containers for DS/TS sets
• Tubing clamp located on each platelet storage container sampling SPC 00644-2
tubing segment SPC 00645-5
SPC 00646
22 Platelet Storage The platelet storage container spike port design shall incorporate the Sterility and regulatory Part B, Section SPC 00342
Container Spike Ports following: 3.7
DES-TPP 00258 R030 SPC 00642-2
• Final storage containers must meet hospital requirement for transfusion
ports. DES-TPP 00168 SPC 00643-2
• Provide 2 sterile entry ports on each Platelet Storage Container that Standard practice and SPC 00644-2
meet local regulation for tamper evidence. customer input; 21 CFR
SPC 00645-2
640.24 (f)
SPC 00646
ISO3826

Cerus Corporation
Design Dossier
23 Packaging The packaging design shall incorporate the following: Functional, Ease of Use Part B, Section SPC 00342
• Each processing set contains an organizer to assist in manufacturing 3.7
ISO 11607 SPC 00642-4
and assembly Part B, Section
DES-TPP 00258 R039 SPC 00643-4
• Each processing set is stored in a 2-compartment pouch 9.0
• 6 processing sets are stored in a foil pouch DES-TPP 00258 R040 SPC 00644-4
• Include a final shipping container with partitions DES-TPP 00168 SPC 00645-4
• Meets necessary Regulatory and industry requirements for tamper SPC 00646
evidence in countries where used
• Shipping container with a pack factor of 24 Processing Sets
• The packaging materials and sets shall not exceed a total weight of
20.8 lbs.

Cerus Corporation
Table 3-7 INTERCEPT Processing Set for Platelets Design Specifications with Alternate Plastics – Functional Requirements
Justification or Design Dossier Supportive Data
Item Product Attribute Minimum Requirement Rationale Reference
FUNCTIONAL REQUIREMENTS
24 Pre-illumination A nominal volume and dose of amotosalen solution (15 mL of 3 mM solution System Requirement Part B, Section Platelets in
Amotosalen for SV, 17.5 mL of 3 mM solution for LV/DS, or 15mL of 6mM solution for 4.3 PAS:
Concentration TS) results in a pre-illumination concentration within the range of 120 to 180
PRD 00330
µM.
DES-RD-DIOM
00222
Platelets in
100% Plasma:
PRD 00374
25 Percent Residual For a nominal input volume, the percent residual amotosalen post-Illumination System Requirement Part B, Section Platelets in
Amotosalen Post- is as follows: 4.3 PAS:
SUD 00852
Illumination - PLATELETS IN PAS PRD 00330
• 10.0 - 39.6% SUD 00853
DES-RD-DIOM
PLATELETS IN 100% PLASMA 00222
• 31.8 - 57.5%
Platelets in
100% Plasma:
PRD 00374

Cerus Corporation
26 Residual Amotosalen PLATELETS IN PAS Functional Part B, Section SUD 00877
Concentration Post- SV/TS: Requirement 4.3
Platelets in
CAD Processing with • Residual amotosalen concentration is ≤2µM on an individual replicate DES-TPP 00258-R015 PAS:
Minimum CAD basis after 4 hours of CAD exposure across all input parameters and and R022
Exposure Time ≥60 rpm agitation PRD 00328
DES-TPP 00168
• Mean residual amotosalen concentration ≤0.5 µM after 4 hours of CAD PRD 00330
exposure with nominal platelet input parameters and 60 rpm agitation DES-RD-DIOM
LV/DS: 00222
• Residual amotosalen concentration is ≤2µM on an individual replicate Platelets in
basis after 6 hours of CAD exposure across all input parameters and 100% Plasma:
≥60 rpm agitation
PRD 00363
• Mean residual amotosalen concentration ≤0.5 µM after 6 hours of CAD
exposure with nominal platelet input parameters and 60 rpm agitation PRD 00374
PLATELETS IN 100% PLASMA
LV/DS:
• Residual amotosalen concentration is ≤2µM on an individual replicate
basis after 16 hours of CAD exposure across all input parameters and
≥60 rpm agitation
• Mean residual amotosalen concentration ≤0.5 µM after 16 hours of CAD
exposure with nominal platelet input parameters and 60 rpm agitation

Cerus Corporation
27 3 J/cm2 UVA The Illumination Container and UVA Illuminator Settings must ensure a System Requirement Part B, Section SUD 00877
Treatment 3 J/cm2 treatment, as determined by post-illumination actinometry 4.3
(amotosalen concentration measurement) Platelets in
PAS:
PRD 00330
Platelets in
100% Plasma:
PRD 00374
28 Device Fit in the • Processing Set must fit in tray compartment of the UVA Illumination Functional Part B, Section PRD 00330
Illuminator Device (Illuminator). Requirement 12.0
DES-RD-DIOM
• Must allow scanning by UVA Device. DES-TPP 00258 R048 00222

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29 Method of Sterilization INTERCEPT Processing Sets for platelets have a Sterility Assurance Level Design and Part B, Section Fenwal FC-
and Surface (SAL) of 10-6 after the following methods of sterilization: Manufacturing 10.0 VAL-16-075
Treatment • An amotosalen-filled subassembly (“wet-side”): steam sterilized to SAL of requirement (steam)
10-6 DES-TPP 00258 Fenwal FC-
• Illumination container, CAD container, in-line filter, platelet storage VAL-16-154
DES-TPP 00168
container(s), and all tubing, cannula, ports, y-junctions (“dry-side”): (gamma)
sterilized by gamma irradiation (the dry side”) to SAL of 10-6 ISO 17655
Fenwal FC-
• Tubing connections for “wet” and “dry” sides: sterilized by e-beam ISO 11137 VAL-17-008
irradiation to SAL of 10-6 (e-beam)
• The entire processing set shall be subjected to ozone as part of the final Fenwal FC-
packaging process to achieve a Spore Log Reduction of 2.5 for all external VAL-17-009
set surfaces for the purpose of preventing mold growth during storage (ozone)
FC-VAL-16-151
(PQ lot release
testing)
SPC 00107
SPC 00468

Cerus Corporation
30 Materials Selection - The Processing Set and materials (Raw Materials, Assembled Components, Design and Part B, Section PRD 00329
Sterilization Labels, and Packaging) must be compatible with the applied methods Manufacturing 10.0
Compatibility PRD 00330
sterilization: requirement
FC-VAL-16-151
Materials used in the “wet-side” subassembly shall be compatible with:
(PQ lot release
• Steam sterilization at 121°C for 35 min. testing)
• 1X ozone exposure PRD 00343
Materials used in the “dry side” subassembly shall be compatible with: PRD 00344
• Gamma irradiation max dose
PRD 00355
• 1X ozone exposure
PRD 00356
Tubing used in connection of “wet” and “dry” sides shall also be compatible
with:
• E-Beam irradiation max dose
• 1X ozone exposure

Cerus Corporation
31 Materials Selection – The Processing Set and all materials with potential for contact with platelets Safety and Regulatory Part B, Section SUD 00878
Biocompatibility/ shall meet the following from ISO10993: ISO10993 4.1
SUD 00879
Physico –Chemical • External Communicating Device with limited contact exposure except for EP monographs for
platelet storage container with its prolonged contact exposure containers and SUD 00880
containers for blood (series)
• Container materials shall meet the relevant EP/USP physico/chemical
and blood components SUD 00882
requirements.
USP<661> (series)
SUD 00883
SUD 00884
SUD 00885
SUD 00886
SUD 00888
SUD 00889
Renolit
Certificate of
Compliance
Fenwal Annual
EP/ISO Testing
32 Materials Selection - • The illumination container material shall have >80% transmissivity of Functional Part B, Section SUD 00864
Light Transmissivity UVA light energy in the wavelength 320-400 nm range Requirement 4.3
PRD 00361
• The illumination container port, tubing, and breakaway closure shall be
PRD 00362
sufficiently transparent to UVA light to allow efficient pathogen
inactivation/reduction

Cerus Corporation
33 Materials Selection – The Platelet Storage container material shall obstruct the bag-in-place sensor Functional Part B, Section DES-VER 00327
Illuminator Bag-in- of the Illuminator when placed in the illumination tray. Requirement 4.3
DES-VER 00328
Place Sensor
34 In-Line filter The in-line filter prevents loose beads from the wafer from entering the Functional Part B, Section PRD 00329
particulate matter platelet storage container Requirement 4.3
removal
35 Tubing bonds All tubing bonds shall withstand a tensile strength of 5 lb for 15 seconds ISO 3826-1 Part B, Section PRD 00329
strengths 4.3
FC-VAL-16-151
Part B, Section (PQ lot release
8.0 testing)
FC-VAL-16-039
36 Cannula Integrity Shall prevent fluid flow up to pressures representative of the peak pressure Functional Part B, Section Fenwal FC-
observed during INTERCEPT process Requirement 4.3 VAL-15-020
Part B, Section PRD 00330
8.0
37 Hanger hole strength Shall be able to withstand a tensile force of 5 lb for 60 minutes ISO 3826-1 Part B, Section PRD 00329
4.3
FC-VAL-16-151
Part B, Section (PQ lot release
8.0 testing)

Cerus Corporation
38 Tubing Clamps • Mechanical assistance shall not be required to occlude tubing using a Functional Part B, Section Fenwal FC-
Occlusion Tubing Clamp Requirement 4.3 VAL-15-118
• Mechanical assistance shall not be required to disengage a Tubing Clamp Part B, Section PRD 00330
• Tubing Clamps shall be designed to interface with tubing to completely 8.0
occlude the fluid pathway and prevent flow when subjected to the peak
pressure associated with INTERCEPT treatment (no leaks during intended
use)
39 Platelet Storage When a closure-piercing device conforming to ISO 1135-4 is inserted into the ISO 3826-1 Part B, Section PRD 00349
Container Spike Port blood bag port, the platelet storage container spike port shall resist a pull force 4.3
Strength of 15N for 15 seconds
40 Integrity testing The Processing Set and components thereof shall withstand maximum in- Product integrity Part B, Section PRD 00329
process pressures with the INTERCEPT treatment process (i.e., no leaks 4.3
PRD 00330
during intended use of the product)
Part B, Section
FC-VAL-16-151
8.0
(PQ lot release
testing)
41 Processing Duration SV/LV: DES-TPP 00258 R020 Part B, Section PRD 00376
The time to perform treatment with the single dose configurations of the 4.4
DES-TPP 00258 R021
INTERCEPT Blood System for platelets for trained operators not to exceed
15 minutes, excluding unaided adsorption incubation time or illumination
time.
DS:
The time to perform treatment with the dual storage container configuration of
the INTERCEPT Blood System for platelets for trained operators not to
exceed 25 minutes, excluding unaided adsorption incubation time or
illumination time.

Cerus Corporation
42 Platelet Agitator Fit During the CAD step, INTERCEPT set components must fit on platelet DES-TPP 00258 - Part B, Section SPC 00342
agitators that have shelves with minimum 1” vertical spacing. R025 3.7
SPC 00642-2
SPC 00643-2
SPC 00644-2
SPC 00645-2
SPC 00646
43 Labeling The product shall contain labels on the following components: Regulatory and Part B, Section SPC 00342
• Amotosalen container Customer requirement 3.7
SPC 00642-1
• Platelet storage container ISO 3826-2, -4
SPC 00643-1
• Foil Pouch
SPC 00644-1
• Shipping Carton
SPC 00645-1
The carton shall contain a Package insert/Instruction for Use
SPC 00646

Cerus Corporation
44 Label Artwork Label and label artwork shall meet all applicable regulatory requirements, Regulatory and Part B, Section SPC 00235
standards and customer requirements Customer requirement 7.0
ISO 15223
ISO 3826-2, -4
DES-TPP 00258 R037
DES-TPP 00258 R038
45 Labeling Integrity Labels shall adhere and be legible after exposure to temperature and Regulatory, Customer Part B, Section Fenwal
humidity conditions associated with manufacture, sterilization, and functional 4.3 FC-VAL-16-043
transportation, storage, and use of the product requirement
PRD 00329
46 Packaging The packaging shall: Regulatory and Part B, Section PRD 00329
Performance • Protect the product from damage due manufacture, transportation, and Customer requirement 9.0
storage of the product ISO 11607
• Protect the integrity of the sterile fluid path during transportation and DES-TPP 00258 –
storage of the product R039
• The packaging shall protect the CAD to prevent adsorption of volatile
impurities from the environment DES-TPP 00258 –
R041
DES-TPP 00258 –
R042

Cerus Corporation
47 Packaging The packaging shall: Functional requirement Part B, Section PRD 00341
Performance - • The packaging shall minimize evaporation from amotosalen solution and 4.3
PRD 00342
Amotosalen Stability shall provide photo-protection during transportation and storage Part B, Section
• Packaging allows for routine processing within the blood center: 5.0
o Out of foil pouch stability: Must use within 8 hrs
o Open pouch stability: Use within 20 days
o Return to pouch stability: Not allowed
48 Expiry Dating (Shelf Disposable processing sets have a minimum of 24 months shelf life DES-TPP 00258-R043 Part B, Section PRD 00329
Life) - Disposable 4.3
PRD 00330
Device
Part B, Section
PRD 00343
5.0
PRD 00344
Part B, Section
9.0 PRD 00345
PRD 00355
PRD 00356
PRD 00357
Fenwal
FC-DEV-16-021
49 Expiry Dating (Shelf The bulk amotosalen HCl is stable at room temperature for a period of Stability for product Part B, Section SPC 00014
Life)- Bulk 60 months formulation 5.0
PRD 00072
Amotosalen
HCl PRD 00157

Cerus Corporation
50 Quality Disposable incidents per million (IPM) within customer’s acceptable range. DES-TPP 00258-R034 N/A Product defect
Target <500 IPM 24 months post-launch IPM will be
monitored and
reported to
management
post-launch

Cerus Corporation
Table 3-8 INTERCEPT Processing Set for Platelets Design Specifications with Alternate Plastics – Interface and Safety Requirements
INTERFACE AND SAFETY REQUIREMENTS
51 Device must specify Instructions for Use must specify the treatment parameters for the platelets to DES-TPP 00258 – Part B Section SPC 00079-AW
requirements for input be processed R036 7.0
SPC 00080-AW
platelets and
INTERCEPT SPC 00123-AW
treatment
SPC 00466-AW
52 Device Usability/ • The device must demonstrate the following with respect to operator DES-TPP 00258-R019 Part B Section DES-FMEA
Human Factors (Ease interface: 2.0 00210
DES-TPP 00258 –
of Use)
• Ability to load disposable processing set into dark side of illumination R048 DES-FMEA
tray with minimal manipulation 00253
DES-TPP 00258 –
• Orientation of final storage container label facilitates barcode scanning R049 DES-FMEA
when storage containers and tubing are loaded into the dark side of the 00313
illumination tray Ease of use by operator
• Ability to manually remove air from all final storage containers (i.e., no
mechanical assistance)
• Disposable processing set should have a hanging mechanism to facilitate
easy platelets drainage and air removal from the final storage containers
• Disposable processing set should include clamps to facilitate ease of
processing
• The disposable processing set should be compatible with current storage
and processing equipment.

Cerus Corporation
53 Ergonomics The INTERCEPT Blood System shall enable safe and effective use when DES-TPP 00258-R019 Part B Section DES-FMEA
used by intended users in the intended use environments 2.0 00210
DES-FMEA
00253
DES-FMEA
00313
54 Endotoxin The Disposable Set shall have endotoxin levels no greater than 20 EU/device Regulatory Part B, Section SPC 00107
(0.125 EU/mL) (Dry Set endotoxin level + Wet Set endotoxin level), as tested Requirement 3.6
SPC 00468
using the appropriate testing specification.
USP<85>, USP <161>, Part B, Section
Fenwal FC-VAL-
EP 2.6.14 8.0
16-151 (PQ
release testing)
55 Particulate Matter The Wet Set shall comply with Small Volume Injection (SVI) particulate Regulatory and safety Part B, Section PRD 00329
matter limits as outlined in USP <788>, Particulate Matter Evaluation for requirement 4.3
Fenwal FC-VAL-
Solution.
USP <788> Part B, Section 16-151 (PQ
The Disposable Set shall comply with particulate matter limits such that 8.0 release testing)
INTERCEPT-treated platelets meets requirements for Large Volume
Injection (LVI) as outlined in USP <788>.
56 Set Disposal Product labeling will include instructions for disposable of unused and used Regulatory and safety Part B Section SPC 00079-AW
sets requirement 7.0
SPC 00080-AW
Labeling
SPC 00123-AW
DES-TPP 00258 –
SPC 00466-AW
R035

Cerus Corporation
57 Risks and Hazards Potential Hazards and Risk to users and operators shall be reduced to Regulatory and safety Part B Section DES-RMF 00299
acceptable levels requirement 2.0
DES-RMF 00322
ISO 13485
ISO 14971
58 Processing Set INTERCEPT Processing Sets, INT100 Illuminator, and INTERCEPT Blood Regulatory Part B Section REF 00681
Standard System must meet applicable harmonized European standards and compendia requirement 14.0
REF 00981
and be a CE Mark approvable device.
DES-TPP 00258 Part B Section
16.0
59 Safety Data Sheet There shall be an established safety data sheet for Amotosalen HCl and Regulatory and Safety Part B, Section SPC 00314
(SDS) solution 5.0
SPC 00315
60 Environmental Impact Meets regulatory requirements for environmental impact Regulatory and Safety N/A Design Dossier

Cerus Corporation
3.6 Product Release Criteria for the INTERCEPT Processing Set for Platelets
• Certificate of Conformity, C02-Test-F
• Final Analysis (pH) after connection, C45-Test-A
• Final Chemical Analysis, Spec FC-231516001
• Final Physical Testing, C06-Test-C
• Bioburden Testing, C18-Test-F
• Copies of the labels used
• Batch exception summary
The release specifications for these tests (SPC 00107 for SV, LV and DS and SPC 00468
for TS set) are provided in the tables below. As part of this change for alternate plastic
materials, Fenwal updated its sterilization technology by upgrading its steam sterilization
equipment to a new Fedegari FOA8/AB autoclave to be used on INTERCEPT Processing
Sets with alternate plastics (Design Dossier Part B, Section 10.0). As a result of the new
steam sterilization equipment, Cerus is also making a change to sterility testing used for
product release. Current sterility lot release testing is conducted by parametric release. Due
to use of alternate plastic materials and new autoclave equipment for steam sterilization,
Cerus will be using lot by lot release testing for sterility for INTERCEPT Processing Sets
with alternate plastics.
Table 3-9 Certificate of Conformity Testing

Component Information
Final product Product code, Batch number, Expiry date, Description, Quantity, Reviewed
by Fenwal QA Manager or Delegate
Amotosalen solution sub Code, Lot, Amotosalen RM batch, Filled container sheeting master batch
assembly number
PCT sub assembly Code, Lot, Porex RM batch
Attribute Method/Reference Specification
Pyrogenicity (Bacterial TEST-B-03 (LAL Kinetic Final Product ≤0.125 EU/mL
Endotoxins) Turbidimetric) Amotosalen sub assy: ≤2.0 EU/mL (3mM)
Amotosalen sub assy: ≤0.8 EU/mL (6mM)
PCT sub assy: ≤0.25 EU/mL
Bioburden TEST-B-09, TEST-B-17, Pass
(Report attached)
Final Physical Testing TEST-C Pass
(Report attached)
Final Chemical analysis on TEST-A-01 Pass
Amotosalen (Report attached)

Cerus Corporation
pH Analysis on Connected Kit TEST-A Pass
(Report attached)
Sterilization According to validated Amotosalen solution: steam sterilization
method reviewed and PCT: Gamma irradiation
conform Final product: E-beam irradiation
Sterility Test TEST-B-13 No Positives
(for alternate plastics only)
Table 3-10 Final S-59 Analysis (pH) after Connection Testing

Attribute Method Specification
Alert Limit Product Limit
pH 11-21-16-003 4.5 – 6.0 3.5 – 6.0
Table 3-11 Final Chemical Analysis, Solution Amotosalen

Amotosalen solution sub assembly Code, Lot
Attribute Method Specificationa
Color QCLABG036 Y6 (alert limit)
(EP2.2.2) Y5 (product limit)
For TS Set:
GY4( alert limit)
GY3 (product limit)
Clarity EP2.2.1 Clear
Particulate Matter QCLABG011 ≥10 µm: NMT 6000 per container
≥25 µm: NMT 600 per container
Amotosalen 11-25-09-481 Positive identification
SV, LV and DS Specifications
Chloride EP2.3.1a Positive identification
Sodium QCLABG031 153 – 163 mEq/L 150 – 182 mEq/L
Amotosalen concentration 11-25-09-481 0.98 – 1.04 g/L 0.96 – 1.16 g/L
Amotosalen dose (15 mL) 11-25-09-481 14.41 – 15.91 mg 14.11-16.21 mg
Amotosalen dose (17.5 mL) 11-25-09-481 16.81 – 18.56 mg 16.46 – 18.92 mg
4’-HMT (4’Hydroxy-4, 5’, 8-tri- 11-25-09-481 NMT 2 mg/L NMT 10 mg/L
methylpsoralen)
Peak A (Furan Diol) 11-25-09-481 NMT 0.4% NMT 1.0%
Unspecified individual impurities 11-25-09-481 NMT 0.2% NMT 0.5%
Total unspecified impurities 11-25-09-481 NMT 0.4% NMT 2.0%
TS Specifications
Sodium QCLABG031 153 – 163 mEq/L 150 – 182 mEq/L
Amotosalen concentration 11-25-09-481 1.97 – 2.13 g/L 1.93 – 2.33 g/L
Amotosalen dose (15 mL) 11-25-09-481 28.9 – 32.0 mg 28.3 – 32.6 mg
4’-HMT (4’Hydroxy-4, 5’, 8-tri- 11-25-09-481 NMT 0.3% NMT 1.2%
methylpsoralen)

Cerus Corporation
Peak A (Furan Diol) 11-25-09-481 NMT 0.2% NMT 1.0%
Unspecified individual impurities 11-25-09-481 NMT 0.2% NMT 0.5%
Total unspecified impurities 11-25-09-481 NMT 0.3% NMT 1.0%
Total chromatographic impurities 11-25-09-481 NMT 0.7% NMT 3.2%
a
NMT = not more than.
Note: Alert limits are product release specifications. Product limits are end of shelf life specifications.
Table 3-12 Bacteriology-Bioburden Testing

Product Sampling Method Specificationa
Final Product Each day of connection, TEST-B-09 TC ≤10 cfu/unit
3 units
Amotosalen solution sub 3 units start of batch TEST-B-17 TC ≤290 cfu/unit
assembly 2 units end of batch CC ≤29 cfu/unit
SC ≤5 cfu/unit
PCT sub assembly 1 batch per week, 3 units TEST-B-09 TC ≤40 cfu/unit
a
TC = Total; CC = Coliforms; SC = Spores.
Table 3-13 Final Physical Testing

Final product Code, Lot, S-59 batch number
Attribute Specification
Physical Tests, TEST-C (20 each tested either per connected batch or per amotosalen batch)
Hang test at e-beam connection 0 non-conforming per 20 tested
Clear passage test at e-beam connection 0 non-conforming per 20 tested
Conformity product vs. BOM/drawing 0 non-conforming per 20 tested
Verification of product structure 0 non-conforming per 20 tested
Barcode reading test Final storage container 0 non-conforming per 20 tested
Label conformity
S-59 container 0 non-conforming per 20 tested
Final storage container 0 non-conforming per 20 tested
Label adhesion
S-59 container 0 non-conforming per 20 tested
Final storage container 0 non-conforming per 20 tested
Port opening 0 non-conforming per 20 tested
Product airtightness
Assembly 0 non-conforming per 20 tested
Bag 0 non-conforming per 20 tested
Cannula 0 non-conforming per 20 tested
Manual cannula breakage 0 non-conforming per 20 tested
Solution volume Average of 5 inspected
15 mL: 14.70 – 15.30 mL
17.5 mL: 17.15 – 17.85 mL
Internal sticking of walls in amotosalen bag 0 non-conforming per 5 tested
Particles in solution 0 non-conforming per 5 inspected
Final visual inspection on sample size level 1 0 non-conforming per total tested

Cerus Corporation
3.6.1 Labeling Verification
Copies of the following labels used for the batch (Refer to Design Dossier, Part B
Section 7.0 for label part numbers):
• Amotosalen solution
• Storage bag
• Foil pouch
• Carton
• Front page of IFU
3.7 Representative Bill of Materials
INTERCEPT Platelet INTERCEPT Platelet

Processing Set Processing Set
Description (Current Plastics) (Alternate Plastics)
Platelet SV Packaged Set SPC 00132-1 SPC 00642-1
Platelet LV Packaged Set SPC 00134-1 SPC 00643-1
Platelet DS Packaged Set SPC 00207-1 SPC 00644-1
Platelet TS Packaged Set SPC 00467-1 SPC 00645-1
3.8 Referenced Documents
• SPC 00107, INTERCEPT Platelet SV, LV, DS Processing Set Release

Specification
• SPC 00468, INTERCEPT Platelet TS Processing Set Release Specification
• SPC 00642-1, Platelet SV Connected Set – Alternate Plastics
• SPC 00643-1, Platelet LV Connected Set – Alternate Plastics
• SPC 00644-1, Platelet DS Connected Set – Alternate Plastics
• SPC 00645-1, Platelet TS Connected Set – Alternate Plastics

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Cerus Corporation

INTERCEPT Blood System for Platelets

3 DRAWINGS, DESIGN AND PRODUCT SPECIFICATIONS ...........................3

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3 DRAWINGS, DESIGN AND PRODUCT SPECIFICATIONS

3.1 Executive Summary of Product Design

The INTERCEPT Platelet Processing Set is offered in four configurations:

• Amotosalen solution container

• Illumination container for the platelets during INTERCEPT treatment

• Compound Adsorption Device (CAD) container for the reduction of residual

• Storage containers for platelet storage prior to transfusion

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of transfusion-associated graft-versus-host disease (TA-GVHD). INTERCEPT treatment

3.2 Background and Description of Change

• Though European Pharmacopoeia and MDD 93/42/EEC allows for DEHP to be

• Use of commercially available medical-grade plastics (versus custom-produced

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intended use of the INTERCEPT Blood System or INTERCEPT treatment process as a

3.2.1 Plastics Materials Changes

Table 3-1 Proposed Plastic Material Changes for the INTERCEPT

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3.2.1.1 Design Changes

3.2.1.1.1 Amotosalen Solution Container

Figure 3-5 INTERCEPT Processing Set Amotosalen Solution Container

3.2.1.1.2 CAD Container for the Dual Storage Set

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3.2.1.1.3 Other Design Changes

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Figure 3-7 INTERCEPT Processing Set Tube Clamps

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3.3 Comprehensive Description of the INTERCEPT Blood System for Platelets

3.3.1 INTERCEPT Processing Set for Platelets

The INTERCEPT Platelet Processing Set is offered in four configurations:

Each INTERCEPT Platelets Processing Set is provided as integral containers in a sealed

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3.3.1.1 INTERCEPT Processing Set for Platelets Key Components

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Table 3-2 Key Components of the INTERCEPT Platelets Processing Set

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3.3.2 INTERCEPT Illuminator

The INTERCEPT Illuminator is an accessory that delivers a controlled amount of UVA

3.3.3 Mechanism of Action

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Figure 3-11 Pictorial View of the Mechanism of Action

3.3.4 Platelet Processing Using the INTERCEPT Sets

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Section 3.4.1, Amotosalen Solution Subassembly (Wet-Side)

Section 3.4.2, Photochemical Treatment Disposable Subassembly (Dry-Side)

Section 3.4.2.1, Illumination Container

Section 3.4.2.2, CAD Container

Section 3.4.2.3, Storage Container

Section 3.4.3, Label Material

Section 3.4.4, Packaging Design

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5 Amotosalen Container (20mL) Baxter PL 2411(film) Renolit Infuflex 7234 (film)

6 Bag Label - Amotosalen Container Teslin Same as current

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3.4.1 Amotosalen Solution Subassembly (Wet Side)