OEB Isolator – Closed isolator, negative pressure isolator, containment isolator, OEB5 isolator Containment System is a barrier designed to prevent dangerous materials from dispersing in the surrounding environment.
OEB Isolator – Closed isolator, negative pressure isolator, containment isolator, OEB5 isolator
A Containment System is a barrier designed to prevent dangerous materials from dispersing in the surrounding environment. According to the Operator Exposure Band, it can be a completely sealed and closed Isolator (compulsory for OEB 4,5) or a Containment Cabinet with one or more “mouse holes” opened to the external environment (for the passage of conveyor belts of other transfer devices).
In today’s world of advanced medications, the pharmaceutical industry has seen a growing number of products with potential health risks to those working with them. Potent active compounds in the form of airborne dust, in particular, can put the operator at risk with all related adverse effects (respiratory, dermatological or reproductive).
The increasing use of API (Active Pharmaceutical Ingredients) in the industry is playing a prominent role in fighting illness and disease with great benefits to the patients but with a greater potential impact on worker’s health.
In order to reduce or eliminate such risks of cross-contamination, limiting the impact to the outdoor environment and minimizing costs, the industry has embraced Good Manufacturing Practices (GMPs) for the satisfactory containment of production processes.
isolator based on standard design, refer to current technical specification specific item configuration.
NO. | Function Requirement | Acceptance Criteria |
1 | Electric current, voltage | 380V/50Hz |
2 | power | 1500W |
3 | Air way | Turbulent flow |
4 | air cleanliness class | class D |
5 | Differential pressure | 0~-80Pa |
6 | Protection grade | OBL 1-10ug (OEB4) |
7 | Leakage standard | ISO10648-2 Q/V≤0.5% |
8 | Explosion-proof grade | ExdIIBT4(Electrical components) |
S/N | Item | Spec. | QTY |
1 | Inside chamber | Stainless steel 316L*3mm,
Mirror polishing |
1 SET |
2 | Inside transfer chamber | Stainless steel 316L*3mm
Mirror polishing |
1 SET |
3 | Frame/shell | Stainless steel 304*2mm
Wire drawing processing |
1 SET |
4 | Transfer chamber door | Tempered safety glass, 15mm thick | 1 SET |
5 | Transfer chamber door Gas filling seal strip | Silicone | 2 SET
(Set aside 1) |
5 | Operation chamber door | Tempered safety glass, 15mm thick | 1 SET |
6 | Operation chamber door Gas filling seal strip | Silicone | 2 SET
(Set aside 1) |
7 | Middle transfer door | Stainless steel 316L | 1 SET |
8 | Middle transfer door
Gas filling seal strip |
Stainless steel 316L | 2 SET
(Set aside 1) |
9 | oval glove port(8 “) | POM | 6 SET |
10 | glove(8 “) | CSM | 8 SET(Set aside 2) |
11 | Prefilter | G4 | 2 PC(Set aside 1) |
12 | Toxic Filter | ref32020400 | 3 PCS(Set aside 1) |
13 | Air exhaust HEPA filter(PUSH-PUSH) | DN150 | 6 PCS(Set aside 2) |
14 | HEPA filter pressure differential gauge | D2000-500,0-500pa | 5 PCS |
15 | PUSH – PUSH installation tube | DN150 | 2 SETS |
16 | push-push replacement kit | Push rod replacement | 1 SET |
17 | BIBO | DN280 | 1 SET |
18 | Exhaust fan | H550DG | 2 SET |
inverter | 1.5KW | 2 SET | |
19 | Exhaust pneumatic valve | DN51 | 2 SET |
20 | Admission valve | DN51 | 2 SET |
21 | Manual ball valve | DN51 | 2 SET |
22 | Drain valve | DN25 | 2 SET |
23 | Water/air spray gun | SG-1-01 15 | 2 PCS |
24 | lamp | LED150 Explosion-proof box | 3 PCS
(Set aside 1) |
25 | HMI | TP700 | 1 SET |
25 | HMI Audit Trail | TP700 | 1 SET |
26 | PLC | S7-200SMART | 1 SET |
27 | Analog quantity module | EM06 | 1 SET |
28 | Intermediate relay | MY2NJ-24V
With base |
10 SET |
29 | Circuit breaker | EA9AN2C16 | 1 SET |
30 | abrupt stop switch | GHS-1122 | 1 SET |
31 | Solenoid valve | 24v1-1 | 12 SET |
32 | Pressure sensor | SM111 0-500pa | 2 SETS |
33 | Explosion-proof box | 400*400mm | 1 SET |
34 | Switch power | NED-100B | 1 SET |
35 | Electronic scale | 64KG/0.1g | 1 SET |
36 | Shock absorber for electronic scale(marble) | 350*400*70mm | 1 SET |
37 | Built-in glove integrity tester | DZ-320 | 1 SET |
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QC Isolators – Quality Control isolators, QC lab flexible isolators are designed with you in mind to improve your work safety and quality, testing of Raw materials, packing materials, Semi-finished, Finished products and stability testing for OSD and Injectable Oncology products, Microbiology lab is equipped to perform all the applicable microbiological tests including method development and validation e.g., Sterility testing under isolator.
Granulation Line Isolators, Isolator for Granulation line – Containment OEB 5, Granulation Line Isolators -Complete Granulation line consisting of Sifter, RMG, FBD, Cone mill and Blending fitted in a single isolator chamber thus complying to required OEL levels.
Manufacturer for isolator, Quadro mill, Air jet mill, VTD, FBD, RMG, Blenders, Mills, Shifters, PNF, CIP/SIP, Dynamic and static pass box etc Pharmaceuticals and Biotech, Sterile, API, equipment. Pharmaceutical | Bulk Drugs | Chemicals | Food | Beverage | Biopharmaceuticals | Agrochemicals | Fine Chemicals | Biochemicals | Nuclear
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