Aseptic powder isolator (APIS-1)

Product ID：1024247
weight：412.00g
Shelf time：2018-12-20 11:07:19
Description：PAPAGO vehicle traveling data recorder full 1080 p hd wide dynamic image processing technology

Product Overview

PRODUCT PROFILE
Product item	Aseptic powder isolator (APIS‑1)
Isolation system	Buffer compartment + operation compartment (double‑sided operation) + discharge compartment, positive pressure
Automatic control system	Industrial control computer, unidirectional laminar flow, meet Class A standards, compliant with audit tracking and electronic signature
VHP sterilization	Integrated VHP generator and concentration sensor
Material transportation	Track transfer of aluminum drums and bags
Aluminum drum manipulator	Lifting, opening, filling, capping, mechanical automation operations
Filling compatibility	2‑250 ml vials
Production capacity	500‑1000 bottles per hour
Filling accuracy	≤ ±0.5‑2%
Filling volume	0.01‑5g
EM detection	Online integrated particle and airborne bacteria online monitoring
Product applications	Aseptic sampling of aluminum drums/bags / Filling of vials
Protected objects	Sterile products

Features：

Designed for aseptic sampling and filling of sterile HAPI raw powder materials;
Double‑sided operation cabin with Class A unidirectional laminar flow environment;
Integrated VHP generator realizes reliable isolator bio‑decontamination cycles;
Automatic aluminum‑drum manipulator reduces manual intervention and contamination risks;
High‑precision powder filling unit supports micro‑dose powder processing;
Online EM monitoring and complete audit‑tracking for regulated pharmaceutical production.

Working Principle

The APIS‑1 aseptic powder isolator adopts positive pressure isolation design. Raw materials are transported into the buffer compartment firstly and undergo VHP bio-decontamination to remove surface microbiological contamination.

Inside the operation compartment, Class A unidirectional laminar flow maintains high-level cleanliness environment. The automatic aluminum drum manipulator completes drum lifting, opening, powder filling and capping without frequent manual intervention. Real-time online particle and airborne bacteria monitoring continuously verifies cleanliness status throughout production. Finished vials are discharged from the discharge compartment, realizing fully contained aseptic powder sampling and filling operations.

Technical Advantages

Full Containment Protection

Positive pressure isolation structure prevents cross-contamination and protects sterile powder products.

GMP & Regulatory Compliance

Audit trail & electronic signature function, fully compliant with pharmaceutical regulatory requirements.

Stable VHP Bio-decontamination

Integrated VHP sterilization system delivers stable and repeatable decontamination cycles.

High Precision Micro-dose Filling

Supports micro-dose powder filling, maintains stable filling accuracy for small-volume vials.

Reduced Human Intervention

Automated aluminum drum handling system greatly minimizes human-induced contamination risk.

Application Scenarios

Aseptic sampling and dispensing of high potent API powder
Sterile powder filling for injectable vials
Pharmaceutical laboratory R&D and pilot production
Small batch commercial manufacturing of sterile formulations
Quality control and stability sample preparation for biotech & pharma industry

FAQ

Q: What is the main application of the APIS‑1 aseptic powder isolator?

A: It is specially designed for aseptic sampling and powder filling of high-potency sterile API, suitable for pharmaceutical pilot test and small-scale commercial production.

Q: Does this isolator comply with GMP requirements?

A: Yes. It supports audit tracking and electronic signature, the internal environment meets Class A cleanroom standard, fully meets GMP pharmaceutical production requirements.

Q: What is the filling volume and accuracy range?

A: Filling volume: 0.01‑5g, filling accuracy ≤ ±0.5‑2%, applicable to 2‑250ml vials.

Q: Can the VHP sterilization function be customized?

A: The integrated VHP generator and concentration sensor are standard configuration. We can adjust decontamination parameters according to your site requirements.

Q: What after-sales and technical support can you provide?

A: We provide on-site installation guidance, commissioning, operator training, long-term spare parts supply and remote technical support.