Pharma Sterile Negative Pressure Isolator Filling Line Manufacturing Company

Pharma Sterile Negative Pressure Isolator Filling Line Manufacturing Company

Pharma isolator Product Description:

The sterile negative pressure filling isolator is mainly used for providing Class A sterile protection for key sterile operating procedures such as the sterile filtration, filling and sealing for sterile, highly toxic and highly active preparations. Sterile isolator reduces the risks of environmental pollution during the aseptic filling and capping production process. The sterile filling isolator is suitable for filling, capping and sterile solution filtration of sterile drugs, XDC-type conjugated drugs, oncolytic viruses and other products with high toxicity and high activity for trial and pilot R&D.

Negative pressure isolator Application:

Virus vector production and filling

• Application scenarios:

Concentration and purification of lentivirus/adenovirus (LV/AAV)

Aseptic filling of gene therapy preparations

• Reasons:

Virus vectors have extremely high requirements for aseptic conditions (must comply with GMP Annex 1). The sterile isolator enables continuous closed operation, eliminating particle and microbial contamination.

Negative pressure isolator can prevent the leakage of virus aerosols (biosecurity protection).

Negative pressure isolator Product features:

The sterile filling isolator system is mainly composed of isolator chamber, air filtration system, sterilization system and control system, which provides sterile Class A protection for the equipment inside the pharma isolator and protects personnel from toxic drugs.

For the production of sterile, highly toxic and highly active drugs, the pharmaceutical isolator technology has the following features:

1. Custom isolator: The sterile filling isolator can be flexibly designed according to the process and is equipped with corresponding functional units such as filtration, filling, and capping;

2. Flexible isolator manufacturing company: Negative pressure isolator can realize the common line production of penicillin bottle and pre-filled needle products;

3. Pharma isolator segmented design: The whole line or individual segments of sterile isolator can be provided with independent leak testing and VHP sterilization;

4. Pressure gradient isolator design: Each segment of filling isolator is connected by airtight valve, which can adjust the differential pressure independently and set appropriate differential pressure for each segment according to the process, which avoids cross contamination;

5. The negative pressure isolator can be integrated with the online environmental monitoring and sampling system of particles and airborne microbes;

6. The sterile filling isolator equipped with RTP barrel/valve transfer device is optional according to supply needs;

7. The wireless glove leak detector can be configured to detect leakage for each glove before production, preventing damage to the internal environment of the pharma isolator from glove breakage;

8. Wash-in-place (WIP) for isolator chamber + clean-in-place (CIP) for air duct can be configured. The sterile isolator bottom plate adopts tilt design, which is easy for facilitating drainage after cleaning;

9. Confirmation of operational risk control: The Mock-UP wood mold and ergonomic testing confirm that the integrity of the filling isolator is not damaged and the airflow is not affected, the glove opening location is reasonable. All interventions will be confirmed before isolator design.

10. Anne Parker is a professional isolator manufacturing company with technical validation service team, combined with a set of scientific and perfect validation management system documents proven by the project practice (including but not limited to RA, DQ, FAT, SAT, IQ, OQ, PQ, etc.), ensures the pharma isolator product quality and reliable validation results.