Customer Reference: Additional DN50 equipment Project Reference: CPT20866

ChargePoint PharmaSafe® Powder transfer containment valves ensure the safer handling of Highly Potent
Active Pharmaceutical Ingredients (HPAPI) and other formulation ingredients, offering the highest levels of
operator protection through validated containment performance.

Applications
ChargePoint PharmaSafe split valves provide a secure common interface for transfer of solids from a wide
range of production processes when handling products within the OEB4 and OEB5 categories.

Fine Chemical Production (e.g. APIs and Intermediates)

Dispensing | Synthesis | Filtration | Drying | Milling | Sieving | Washing

Pharmaceutical Solid Dose Formulation (e.g. Tablets/Capsules)

Dispensing | Granulation | Mixing | Blending | Milling| Tabletting | Encapsulation | IBC Washing

Key Features
Optimum seal design Each seat seal is manufactured within a precise tolerance to ensure an optimum
balance between operability and the containment seal.

Metal-to-metal disc seal No additional solid or inflatable seals ensure a simple GMP design

Single body design A single piece robust design with minimal parts

Secure pressure / A unique method of achieving a pressure seal provides additional benefits for
vacuum rated system powder flow and ability to have valve in open position when under pressure
condition.

Safety interlocks Safety for the process and personnel

Process versatility Can be utilized for multiple process functions: Product charging; Wash In Place;
Sampling; Sightglass viewing port.

Small footprint Retains a compact footprint throughout the size ranges

Operation Principle

© Copyright ChargePoint Technology Ltd 2022 Document Reference: QM7204 Rev 2

Date: 29 March 2022

Customer Reference: Additional DN50 equipment Project Reference: CPT20866

Containment Performance
ChargePoint® split valve containment performance has been independently tested in accordance with the
guideline (SMEPAC) “ISPE Good Practice Guide: Assessing the Particulate Containment Performance of
Pharmaceutical Equipment (Second Edition).”

ChargePoint valves have been shown to perform with the following performance values for airborne exposure
monitoring (task based):

The containment performance values provided are subject to the adherence of correct operation and
maintenance procedures following satisfactory installation.

After a transfer, it should be anticipated that there is a possibility some powder may be visibly present on
the mating interface of each valve half. This is caused by powder remaining on the disc edge during the
closing of the valve and will vary dependent upon the characteristics of the product. As part of the correct
operating procedure, any visible trace of product residue should be removed from both the Active and
Passive units by undertaking a manual wiping process immediately after undocking the valve. It is possible
to apply further techniques to help reduce or eliminate the build-up of residue. Contact ChargePoint
Technology for further information.

ChargePoint Technology recommends that training is provided to new ChargePoint users to assure correct
operation and maintenance. ChargePoint Technology will not be liable for damage to the valve or
containment performance failure owing to incorrect operation of the system.

ChargePoint AseptiSafe: Potent products in aseptic processing

It is also possible to apply the same methods of achieving high containment

performance to the ChargePoint AseptiSafe valve range when handling potent
products in aseptic processing. Contact us for further information.

© Copyright ChargePoint Technology Ltd 2022 Document Reference: QM7204 Rev 2

Date: 29 March 2022

Customer Reference: Additional DN50 equipment Project Reference: CPT20866

Equipment Summary
Description
50mm (2") Active PS
1 PharmaSafe 50mm (2") NB Active
Manual - -1 to 6 Bar G - BS4825 Tri-Clamp
316L Body & Disc - EPDM Seat & O-Rings - N60 - Passivation
Full specifications of Item 1 are included in the following sections 1

50mm (2") Passive PS

2 PharmaSafe 50mm (2") NB Passive
-1 to 6 Bar G - BS4825 Tri-Clamp
316L Body & Disc - EPDM Seat & O-Ring - PEEK - Nitronic 60
Full specifications of Item 2 are included in the following sections 2

50mm (2") Passive GMP Cover

3 50mm (2") NB Passive GMP Cover
Non Pressure Rated
HDPE Body - EPDM O-Ring
Full specifications of Item 3 are included in the following sections 3

50mm (2") - Active Spray Cap

4 50mm (2") NB - Active Spray Cap
-1 to 6.0 Bar G - 1" (25mm) BS4825, 316L Stainless Steel
EPDM O-Ring (White) and Gasket
35l/min @ 1 Bar Sprayball
Full specifications of Item 4 are included in the following sections 4

50mm (2") ChargeBag - 2.5L

5 ChargeBag PE-S - 50mm (2") NB Tri-Clamp- 2.5 Litre-HiPure
ULP7 LLDPE - single PE outer liner - 20 per carton - Non Irradiated
Full specifications of Item 5 are included in the following sections 5

50mm (2") ChargeBottle - 1L

6 ChargeBottle P - 1 Litre - 50mm (2")
Material: FDA Compliant Polypropylene
Documentation and Freight Charges
7 ChargePoint Operation and Maintenance Manual - Electronic
Link Version – English
8 Carriage and Insurance Paid to (insert named place)

© Copyright ChargePoint Technology Ltd 2022 Document Reference: QM7204 Rev 2

Date: 29 March 2022

Customer Reference: Additional DN50 equipment Project Reference: CPT20866

1. PharmaSafe 50mm (2") NB Active

The Active is the driving half of the ChargePoint Split Butterfly Valve. The Active Body is machined out of one
single piece of material which makes it a very robust, solid base for the Active assembly. The Active is
configured so that the valve can only be opened once a Passive or ancillary component is inserted locked in
place via a series of mechanical interlocks.
Product Group PharmaSafe
Size 50mm (2") NB
Type Active
Operation Type Manual
Pressure Rating -1.0 to 6.0 Bar G (87 psi)
Connection BS4825 Tri-Clamp
Body Material 316L Stainless Steel (Product Contact)
Disc Material 316L Stainless Steel (Product Contact)
Seat Material FDA Compliant EPDM (White) (Product Contact)
O-Ring Material FDA Compliant EPDM (White)
Shoulder Bolt Material Alloy 218 (Nitronic 60)
Bushing Material FDA Compliant PEEK (Polyether Ether Ketone)

Finger Guard Material Not included

Product Contact Passivation Active Body & Disc

© Copyright ChargePoint Technology Ltd 2022 Document Reference: QM7204 Rev 2

Date: 29 March 2022

Customer Reference: Additional DN50 equipment Project Reference: CPT20866

2. PharmaSafe 50mm (2") NB Passive

The Passive is the driven half of the ChargePoint split butterfly valve.
It is designed so that it can only be opened once correctly docked
into the Active unit, this is ensured through the use of mechanical
interlocks. Where required the Passive Valve can be pressure rated,
when open, with the addition of an O-Ring around the outer
circumference of the body.

* Images are for illustration only and may not reflect specification
detail on this page

Product Group PharmaSafe

Size 50mm (2") NB
Type Passive
Max working Pressure of Assembly -1.0 to 6.0 Bar G (87 psi) (when mated to Active or PR Passive Cover)
Connection BS4825 Tri-Clamp
Body Material 316L Stainless Steel (Product Contact)
Disc Material 316L Stainless Steel (Product Contact)
Seat Material FDA Compliant EPDM (White) (Product Contact)

O-Ring Material FDA Compliant EPDM (White)

Bushing Material FDA Compliant PEEK (Polyether Ether Ketone)
Peg Material Alloy 218 (Nitronic 60)
Mating Equipment To be used with Series 2 Active

© Copyright ChargePoint Technology Ltd 2022 Document Reference: QM7204 Rev 2

Date: 29 March 2022

Customer Reference: Additional DN50 equipment Project Reference: CPT20866

3. 50mm (2") NB Passive GMP Cover

The Passive GMP Cover locates around a Passive half of the valve
to prevent contamination and damage to the Passive unit when
not docked to an Active valve such as when the Passive (and
attached container) is in storage or during transfer from one process
step to another. For added security the GMP Cover includes an
interlocking pin which prevents the cover from being removed
accidentally once installed.

* Images are for illustration only and may not reflect specification
detail on this page

Size 50mm (2") NB

Type GMP Cover
Pressure Rating None
Body Material FDA Compliant HDPE
O-Ring Material FDA Compliant EPDM (White)

© Copyright ChargePoint Technology Ltd 2022 Document Reference: QM7204 Rev 2

Date: 29 March 2022

Customer Reference: Additional DN50 equipment Project Reference: CPT20866

4. 50mm (2") NB - Active Spray Cap

The ChargePoint Active Cleaning Cap accessory provides effective local in place cleaning or
decontamination (WIP/CIP/SIP) of the Active half of the SBV system. Cleaning efficacy of the product
contact and sealing areas is enhanced with a simple, GMP design that maximises the surface area of the
active unit exposed to the cleaning cycle media. This is achieved by a unique sealing methodology on the
outer perimeter of the cap, eliminating the need for a typical seat/disc component that would otherwise
inhibit cleaning success in a full Passive unit design.

The Active Cleaning Cap accessories mimics a standard passive (without a seat or disc) by locking into the
Active unit to allow the disc to be opened within a sealed environment. Once the cleaning step has taken
place the Active disc is closed, and removal of the accessory can be removed without breaking
containment of the Active valve half.

The elementary ‘Active Cap’ version features a hygienic tri-clamp connection as a means to connect a
steam sterilisation supply for SIP or decontamination media. This wide bore connection also allows for this
version to be utilised as a process vent or an effective wash fluid drain when the Active valve is installed in
the inverted orientation and washing is to be completed from within he process.

The ‘Active Cleaning Cap’ version features an additional pipe section with blind end coupled to the main
body. This houses a welded fixed sprayball supplied via a tri-clamp connection. This version is suited to
provide gross decontamination WIP or CIP processes and can also be utilised as a means of subsequent SIP
processes where required.

When being used in the inverted position the blind end can be removed creating the ‘Active cleaning Cap
with vent/drain’ assembly. The tri-clamp connection end can then be coupled to pipework making this
version ideal for installation in the inverted orientation where the device is utilised for in place cleaning of the
Active and can also effectively drain from the process in addition to its own generated cleaning fluid.

Note: It is not recommended by ChargePoint Technology to spray solvents through a spray ball due to the
explosion risk. ChargePoint Technology recommends that only water and detergents be used.
Size 50mm (2") NB
Type Active Spray Cap
Pressure Rating -1 to 6.0 Bar G
Temperature Range 0°C to 150°C
Connection 1" (25mm) BS4825 Tri-Clamp
Body Material 316L Stainless Steel
O-Ring Material FDA Compliant EPDM (White)
Gasket Material FDA Compliant EPDM
Sprayball Flow Rate 35l/min @ 1 Bar
Mating Equipment To be used with Series 2 Active
Passivation Provided on metallic product contact surfaces according to ASTM
A967

© Copyright ChargePoint Technology Ltd 2022 Document Reference: QM7204 Rev 2

Date: 29 March 2022

Customer Reference: Additional DN50 equipment Project Reference: CPT20866

5. ChargeBag PE-S - 50mm (2") NB Tri-Clamp- 2.5 Litre-

HiPure
The ChargeBag® PE-S is a flexible, single use product container with excellent all-round integrity for
manufacturers that need to transfer powder ingredients between process steps or even facilities,
economically. Manufactured from the proprietary LLDPE film HiPure ULP7, the ChargeBag® PE-S provides an
uncompromised profile for compliance, strength, and successful powder delivery. HiPure ULP7 is a statically
dissipative film to help ensure that powders can be recovered effectively from each transfer. Each
ChargeBag PE-S is constructed in an ISO6 cleanroom, individually packed in a sealed secondary liner and
gamma irradiated ready for use in even aseptic processes. A convenient tri-clamp ferrule connection is
welded directly to the film liner for added integrity and is available in 50, 100 and 150mm (2, 4 and 6”) sizes.
The ChargeBag PE-S is available in standard sizes ranging from 2.5L to 40L. A reinforced handle ensures safe
manual lifting or integration to a automatic hoist or framework.
Type ChargeBag PE-S
Connection 50mm (2") NB BS4825 Tri-Clamp
Volume 2.5 Litre
Connection Material FDA Compliant HDPE
Bag Material HiPure ULP7 LLDPE
Recommended Loading 15kg Max
Irradiation Non Irradiated

© Copyright ChargePoint Technology Ltd 2022 Document Reference: QM7204 Rev 2

Date: 29 March 2022