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
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 |
Multipack is leading manufacturer of pharmaceutical isolators for containment or aseptic applications. Offers a comprehensive range of advanced isolators and clean room equipment for the pharmaceutical, biotechnology, and healthcare industries.
Aseptic Isolator for Aseptic Filling, Sampling, Sterility Testing, Compounding and Dispensing Oeb4.
Oncology laboratory line case:
The customer’s demand is that the sealing grade should reach OEB5, the wet granulation line, the output is about 2-10kg/ batch, according to the batch size, we designed an integrated wet granulation line, the high shear mixer and the fluidized bed are collected into the isolator, the bottom of the fluidized bed discharge for dry grain, can be directly connected to the mixing hopper. Meet customer OEB5 leakage requirements.
Isolator for Oncology Line Equipment – Isolated Wet Granulation Line
Isolated Tablet Press
Isolated Coating Machine
the use of isolators has become standard practice for sterility testing.
Adopts physic barrier method to isolate controlled room from outside environment, and carry out safety operation through sleeve port, air through a microbial retentive filtration system (HEPA minimum), reach isolation absolutely. Meanwhile adopts hydrogen peroxide sterilization technology which can decontaminate material surface in containment room effectively. And its kill ratio can reach 6-log.
Applications
a. Sterility Testing
b. Animal experiment
c. Production isolation.
Feature
a. Combined chamber for option to meet different requirement. as like,experiment chamber, transfer
b. Rapid transmission technology
c. Embed sterility test pump for choice
d. Independent sterilization system: Hydrogen peroxide vapor system
e. PLC control system: Pressure control and monitoring, ensures the environment figures can be controlled and traced.
f. Independent air handling system with HEPA filters for each chamber.
g. All system can be custom-made
Advantage
a. Testing Environment figures monitoring and tracing
b. Significantly cut operating cost
c. Faster cycle times
e. Portable for relocation and storage
f. Integrated testing and decontamination systems
These cutting-edge containment isolator and clean room solutions ensure operator safety, maintain sterile environments, prevent contamination, and provide controlled environments for critical processes, offering a complete suite of equipment to meet the unique needs of pharmaceutical and biotechnology facilities.
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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
Filling Line Isolator for production of sterile liquid and/or semi-solid pharmaceuticals, washing, sterilization tunnels to process glass vials, cartridges, and syringes, Filling lines enclosed in an isolation technology are now widely utilized for the aseptic manufacture of sterile, Vaccine, Aseptic pharmaceuticals in various container formats. Pharmaceutical production lines with aseptic and aseptic-toxic processes Customized Production Isolators
Blister Packing machine with OEB5 containment Isolator system for the packaging of oncological products, the blister machine designed and manufactured by Multipack, Guarantees a maximum level of protection (OEB5).
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