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ZHANGJIAGANG MEDPHARM MACHINERY LTD.
Home ProductsPharmaceutical Autoclave

With Validation Port Program Pharmaceutical Autoclave For Sterilizing Ampoule Injection

China ZHANGJIAGANG MEDPHARM MACHINERY LTD. certification
China ZHANGJIAGANG MEDPHARM MACHINERY LTD. certification
It is worthy to cooperate with Medpharm again. Also, prompt action on after sales service left me a deep impression.

—— Manusawee Wareesuwan

I like the sterilizer here running in our factory,it is wonderful.It is fully made to my requirement.Before that I contact many suppliers but they can

—— Marina.Stolyrova

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With Validation Port Program Pharmaceutical Autoclave For Sterilizing Ampoule Injection

With Validation Port Program Pharmaceutical Autoclave For Sterilizing Ampoule Injection
With Validation Port Program Pharmaceutical Autoclave For Sterilizing Ampoule Injection

Large Image :  With Validation Port Program Pharmaceutical Autoclave For Sterilizing Ampoule Injection

Product Details:
Place of Origin: China
Brand Name: Medpharm
Certification: CE
Model Number: MDA-1.5
Payment & Shipping Terms:
Minimum Order Quantity: 1 pc
Price: Negotiation
Packaging Details: Packed in protection film firstly,and then reinforced with wooden case for outer packing
Delivery Time: 30 working days after received your payment
Payment Terms: T/T in advance, LC AT SIGHT
Supply Ability: 10 pcs per month
Detailed Product Description
Door Type: Motorized Hinge Door Application: Sterilizing Ampoule Injection
Safe Recording: Deliverable Documentation Testing Program: Acceptance Testing
Material: SS304 Chamber,Carbon Steel Jacket Chamber Volume: 1500 Liters
High Light:

Plasma Sterilization Equipment

,

Sterilization Using Autoclave

 

With Validation Port Program Pharmaceutical Autoclave For Sterilizing Ampoule Injection​     

 

 

Applications

 

These series sterilizers are special designed steam autoclaves for sterilizing injections, oral liquid medicines, oral liquid health care products packed into ampoules, vials or tube shaped bottles etc, and with intelligent automatically leak detecting and cleaning function during the sterilization cycle to ensure the leaked bottles easily found and eliminated.

 

Main Parameters

 

Model

MDA-1.5

Door number

Single or double door

Door type

Motorized Hinge Door

Chamber / jacket material

SS304 / Steel

Chamber volume

1500 liters

Chamber Size  

680*1180*1870mm

Overall Size         

1450*2000*2210mm

Net Weight            

2150kg

Steam               

50Kg/cycle

Water           

350Kg/cycle

Power(KVA)

4.5KVA

Working temperature

105---134℃

Sterilization time

0---999min

Temperature difference

≤±1℃

Max working pressure

0.23MPa

Steam

0.4---0.8MPa

Soft water

0.1---0.3MPa

Compressed air

0.4---0.8MPa

Electric power

AC380v, 3P/N/E, 50Hz

 

 

Specification, Documentation & Acceptance Testing

 

To ensure that our pharma autoclaves satisfy your requirements we implement a strict documentation and qualification process according to cGMP regulations. This process starts with defining specifications and expectations which will impact every aspect of manufacturing.

 

Deliverable Documentation

 

Our cGMP documentation process is an integral part of each stage of the project management and manufacturing process. The following is a partial list of documentation that we provide

 

Order Related Documentation

 

  • URS and Compliance
  • Commercial Order Documentation

 

Design Qualification (DQ)

 

  • Pressure vessel design (ASME/PED)
  • Layout drawing
  • General drawing
  • Piping and Pneumatic drawing
  • Electrical drawings
  • Accessories drawings
  • Software Requirements Specification (SRS)

 

Installation Qualification (IQ)

 

  • Chamber radiology testing
  • ASME/PED certificate
  • Surface finish reports
  • List of materials and components (with ID tagging)
  • Sanitary piping and component certificates
  • Datasheets
  • Orbital welding video reports
  • P&ID

 

Operation Qualification (OQ)

 

  • Certification of calibration
  • Validation and test reports

 

Acceptance Testing

 

Each autoclave is subjected to a strict examination in Medpharm’s advanced testing laboratory. Following our internal testing, we invite the customer to conduct a Factory Acceptance Testing (FAT) which includes DQ, IQ , OQ review. In order to facilitate site validation, We provide a Site Acceptance Testing (SAT) service which includes review of documentation, installation and operation of the autoclave.

 

 

With Validation Port Program Pharmaceutical Autoclave For Sterilizing Ampoule Injection 0

With Validation Port Program Pharmaceutical Autoclave For Sterilizing Ampoule Injection 1

 

Brochure load down from here

Medpharm medical large steam autoclave brochure.pdf

 

Contact Details
ZHANGJIAGANG MEDPHARM MACHINERY LTD.

Contact Person: Ms. JULIET

Tel: +8613915466171

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