What certifications does the product have?

The product has CE certification.

Can OEM and ODM services be provided?

Yes, both OEM and ODM services are available with full customization options.

Marya CE Certification Vhp Sterile Pass Box Passbox for Pharmaceutical Workshop Manufacturers

Name: Marya CE Certification Vhp Sterile Pass Box Passbox for Pharmaceutical Workshop Manufacturers
Brand: Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.
SKU: 2228760775

Shanghai, ChinaShanghai Marya Pharmaceutical Engineering & Project Co., Ltd.

US$2,000.00

1 Piece

Product profile

Customization

Available

Optional Accessory

Timer Switch, Intercom, Sterilization Lamp, Floodlight

Noise

0-20db

Surface Treatment

Baking Finish

Inside Diameter

800*800*800mm

Installation

Embedded Type

Operating Principle

Laminar

Type

Self-Cleaning

Whole Power

0.35kw

Power Supply

220V/50Hz

Efficiency

H14, 99.995%

Cleanliness Level

ISO 8

Dimension

Customized

Laminar Flow

70%

Exhaust

30%

HEPA

H14

Main Body Material

Galvanized Steel with Powder Coated

Work Surface

304 Ss

UV Light

Equipped

UV Control Programes

Equipped

Light Intensity

800lux

Front Window Glass

Tempered

Automatic Alarm

Equipped

Transport Package

Export Wooden Package

Specification

Standard/customized

Trademark

Marya

Origin

China

Key features

VHP Sterilization Technology: Controls H2O2 concentration and saturation for high reproducibility and shorter sterilization time.

Intelligent PLC Control: Siemens PLC+IPC system with multi-level authority, meeting FDA 21 CFR Part 11 requirements.

Advanced Safety Interlock: Double-door interlocking, automatic sealing, and anti-opening protection prevent H2O2 leakage.

Customizable Dimensions: Dimension is customized to fit specific workshop requirements and spatial constraints.

Efficient Decomposition Filter: Optional exhaust filter shortens H2O2 degradation time and reduces residual concentration.

CE Certification: Product holds CE certification ensuring compliance with European safety and quality standards.

Low Noise Operation: Operates with noise level of 0-20db, ensuring a quiet environment in pharmaceutical workshops.

Company profile

Flexible CustomizationProduct CertificationYears of Export ExperienceR&D Capabilities

Shanghai Marya Pharmaceutical Engineering & Project Co., Ltd.

Shanghai, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Full Customization, Flexible customization CertifiedExport Year: 12 Years CertifiedNearest Port: Shanghai Port; Ningbo PortAverage Response Time: ≤3.17h

AI-Powered supplier vetting

SummaryThe supplier, Marya, is a combined type company with extensive experience in pharmaceutical and medical industries. It lacks certain service capabilities, such as effective after-sales service and overseas infrastructure. While it excels in customization and maintains strong R&D capabilities, it does not introduce new products frequently. The company has significant export trade capacity, but lacks formal contracts and warehouse facilities.

Supplier typeThe supplier is described as a combined type company with three factories and extensive experience in the pharmaceutical and medical industries.

CertificationsThe company has expertise in securing GMP and FDA certifications for factory construction.

After-Sales capabilityThe supplier lacks written procedures or records for corrective and preventive actions, as well as for handling customer complaints.

Production capacityThe supplier lacks valid contracts for manufacturing capacity and has no in-stock service capacity.

Customization capabilityThe supplier offers full and flexible customization in design services.

Client casesThe supplier has a proven track record since 2014, maintaining relationships with major pharmaceutical companies such as Novartis and Novo Nordisk.

Product Q&A

Q:What is the sterilization principle of this pass box?

It uses VHP (Vaporized Hydrogen Peroxide) technology to control concentration and saturation, ensuring high reproducibility and short sterilization time.

Q:Does the system comply with FDA regulations?

Yes, the intelligent control system meets FDA 21 CFR Part 11 requirements with multi-level authority control.

Q:Is the dimension customizable?

Yes, the dimension is customized to fit specific workshop requirements.

Q:What is the minimum order quantity?

The minimum order quantity is 1 Set.

Q:What is the lead time for production?

Peak season lead time is 1-3 months, while off-season lead time is one month.