USER’S MANUAL

FOR
FLEXIABLE ISOLATOR
(MODEL CS)

Prepared by: PURIEST PHARMACEUTICAL TECHNOLOGY CO., LTD

Pharma Machinery Division
Nanjing, China
Phone: +86 25 86137765
Fax: +86 25 86137965

Date: 2023-08
 User’s Manual for Flexiable isolator

PURIEST CLIENT

PHARMACEUTICAL EQUIPMENT
TECHNOLOGY DOCUMENT NO. REVERSION PROJECT NO.
MODEL
CO., LTD
User’s manual 05 CS

TABLE OF CONTENTS

1． GENERAL ............................................................................................................................................................................ 3

2． DESCRIPTION .......................................................................................................................................................................... 4

3．MAIN PARAMETERS ............................................................................................................................................................... 5

4．INSTALLATION ........................................................................................................................................................................ 6

5．OPERATION............................................................................................................................................................................... 7

6．ATTENTION ..............................................................................................................................................................................11

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 User’s Manual for Flexiable isolator

PURIEST CLIENT

PHARMACEUTICAL EQUIPMENT
TECHNOLOGY DOCUMENT NO. REVERSION PROJECT NO.
MODEL
CO., LTD
User’s manual 05 CS

1． GENERAL

Hello
Thank you to adopt our Flexiable isolator
We strive to perfect in design, development, manufacture, testing and
acceptance, sales and services at all stages of the product. We have always
maintained the closest contact you. Your needs will become a reality in our innovation,
hard work, unity of effort. In order to provide you with faster and better service we will
work harder.
Before using the machine ,please read this manual carefully ,and should
know how to operate this system in correct way to avoid any problem to this
system .

Service Number：+86-13776676275

Service FAX：+86-86137965

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 User’s Manual for Flexiable isolator

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PHARMACEUTICAL EQUIPMENT
TECHNOLOGY DOCUMENT NO. REVERSION PROJECT NO.
MODEL
CO., LTD
User’s manual 05 CS

2． DESCRIPTION

Flexible isolators, also known as soft isolators, are disposable isolators that have the advantages of

low cost, short operating cycle, portability, and high efficiency. They mainly sample transparent film

materials for welding and forming, providing excellent visibility for operation and solving the problem

of long glove distances. Flexible isolators are flexible in use and have a wide range of application

environments, meeting various process requirements

Flexible protective isolators are used for material pre-treatment, small dose powder weighing,

batching, packaging of materials, and the weighing and batching of toxic and harmful materials.

Their negative pressure environment ensures that operators and the environment are not affected by

the product

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 User’s Manual for Flexiable isolator

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MODEL
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User’s manual 05 CS

3．MAIN PARAMETERS

Material
NO. Function Requirement

1 Material TPU 0.3mm

Frame SS304

2 Flow type turbulence

3 Operation pressure -10~- 60Pa

Clean compressed air quantity

4 50L/ min, 0.5Mpa

Overall dimention:
5 2500*1500*1900mm

Work dimension
6 2500*1440*1400mm

Hand gloves quantity

7 5pcs

transfer port
8 300mm

ISO10648-2 standard Q/V≤0.5%

9
Sealing standard
OEB 4- 5

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 User’s Manual for Flexiable isolator

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TECHNOLOGY DOCUMENT NO. REVERSION PROJECT NO.
MODEL
CO., LTD
User’s manual 05 CS

4．INSTALLATION

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User’s manual 05 CS

5．OPERATION

1. Bracket assembly: φ 32 pipes are fixed with splicing bracket screws. 3 inch mobile wheel.

2. Soft isolation installation:

2.1 Firstly, check the front direction of the soft isolation before installation (refer to the drawing), fix

the snap bag on the sex isolator on the stainless steel bracket, and fasten all the top horizontal and

side edges.

2.2 Flexible isolation and stainless steel bottom plate flange connection are connected using a

U-shaped plastic strip clamping method. Clamp the U-shaped plastic strip onto the flange.

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2.3 The continuous bag is reserved to be pulled out from the stainless steel sleeve and clamped with

a U-shaped strip.

2.4 Differential pressure gauge pipe connection, on the flexible isolation differential pressure gauge

handle φ Insert 8mm air pipe

2.6 Filter installation, tighten the O-ring at the reserved port corresponding to the flexible isolation

3. Preparation for use

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3.1 Place the used equipment in isolation.

3.2 Inflate, adjust the air pressure to 60pa, and conduct a pressure maintaining test. Each pressure

measurement should not be less than 3 minutes. ISO10648-2 standard requires Q/V ≤ 0.5%

Leakage rate standard comparison:

L=(PD * 60/SP * T) × 100%

L: Leakage rate

PD: Pressure loss value (pa)=P1-P2

P1: Starting pressure difference

P2: Pressure difference after testing

SP: 101325pa+P1 (one atmospheric pressure value is 101325pa)

T: Test time

For example: (P1 60-P2 59) * 60/(10325pa+60) * 60 * 100%=PD 1 * 60/SP * T101505 *

100%=0.059%

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User’s manual 05 CS

Test method reference: EJ/T1096-1999 Constant voltage method.

3.2 During normal operation, it is recommended to adjust the internal isolation to negative pressure

mode according to the general industry standard of -10pa to 15pa (not mandatory)

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 User’s Manual for Flexiable isolator

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User’s manual 05 CS

6．ATTENTION

1.Soaking test of isolation bags and gloves: soaking for 24 hours

1. Methyl tert butyl ether without abnormalities

2. Acetonitrile without abnormalities

3. Hardening of n-heptane

4. Acetate ester without abnormalities

5. Toluene is normal

6. Tetrahydrofuran complete corrosion

7. Acetone is crushed as soon as it is pinched

8. Methanol without abnormalities

9. Ethanol without abnormalities

10. Dichloromethane crumbles easily when pinched

2.The flexible isolator material is TPU transparent film, and chemical experiments are required

before use in the project. If there is a chemical risk, the use needs to be cancelled.

3. Check the clamping and sealing of the connection port during each installation.

4. Before use, it is necessary to conduct a pressure test and maintain pressure. If there is a leak, it is

necessary to check the leak point and make Sealing

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