GMP Vial Lyophilizer with 21 CFR Part 11-Ready Control

Name: GMP Vial Lyophilizer with 21 CFR Part 11-Ready Control
Brand: SJ SCIENTIFIC LIMITED
SKU: 1995014881

Hongkong S.A.R., HONG KONG, CHINASJ SCIENTIFIC LIMITED

US$40,299.00

1 Set

Product specifications

Model

Product profile

Customization

Available

Condition

New

Shelf Area

1.0 M2

Model NO.

Command SJ-100F(T)

Shelf Temperature Range

-65 C to +65 C

Condenser Temperature

<= -85 C

Ultimate Vacuum

<= 7.5 Mtorr

Stoppering System

Hydraulic Stoppering Option

Pharma Application

Peptides, Proteins, Biologics and Sterile Vials

Transport Package

Wooden Package

Specification

1.0m2 shelf area, 450x600mm shelves

Trademark

Origin

China

HS Code

8419399090

Production Capacity

500/Year

Key features

1.0 m2 GMP-oriented shelf system for peptide and biologics batches

Pharmaceutical-grade GMP design with SCADA control and 21 CFR Part 11-ready data integrity

21 CFR Part 11-ready SCADA with recipes, batch records and audit-trail options

Optional hydraulic stoppering for sterile vial workflows

316L contact surfaces, CIP/SIP options and qualification support

Company profile

SJ SCIENTIFIC LIMITED

Hongkong S.A.R., HONG KONG, CHINA

CertifiedBusiness Type: Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedExport Year: 1 Year CertifiedNearest Port: Ningbo PortAverage Response Time: ≤11.22h CertifiedTerms of Payment: LC, T/T, PayPal, etc.

About Our Factory & Business Background

AddressN/a, Hong Kong, China

Plant Area20 square meters

Number of Employees2

Registered Capital10,000 HKD

International Commercial Terms(Incoterms)FOB, CIF, CFR, EXW

Average Lead TimePeak Season Lead Time: one month Off Season Lead Time: one month

Minimum Order Quantity1 Pc

Supply Chain Partners1

Our Production Capability & Technical Expertise

Main ProductsFreeze Dryer

Our Industry Experience & Global Business Record

Year of Establishment2025-05-06

Main MarketsNorth America, Europe

Repeat Buyers Choice30%~50%

Number of Foreign Trading Staff2

Overseas Agent/BranchNo

Our Certifications, Standards & Industry Recognition

Cooperated with Fortune 500No

Product Q&A

Q:What pharmaceutical products can this GMP lyophilizer process?

It is designed for peptide formulations, proteins, biologics, diagnostic reagents and temperature-sensitive sterile vial products. Final cycle development and validation are product specific.

Q:Can the shelf and vial-loading configuration be customized?

Yes. Shelf spacing, vial format, stopper height, loading arrangement, condenser capacity and utilities are confirmed from the user requirement specification and product drawings.

Q:Does the control system support GMP data integrity and qualification?

PLC/SCADA options support recipes, user access, alarms, trends, batch records, audit trails and a 21 CFR Part 11-ready workflow. FAT, SAT, DQ, IQ, OQ and PQ support is available.