Contract Manufacturing

Arwan is a state of the art sterile manufacturing facility with unique technical capability and operational flexibility. We offer our clients clinical scale and commercial scale services.

At Arwan, Quality has been integrated by design and is being assured by practice. The unique and innovative aspects of the design guarantees our clients with quick access to production slots and optimized batch release time without any compromise on product quality.

Arwan can produce biologic and conventional sterile injectable products in liquid form and freeze dried forms.
The facility is in full compliance with GMP regulations and guidelines.

Arwan provides an integrated range of services which allow our clients to get their drug products manufactured, tested, labeled, packaged, stored, and released in record time. Our experienced project management team offers a single point of contact throughout the project for fast channeling of information and decisions.

Technical Aspects Facility:

State of the art Cleanrooms with access control system
CFR 11 and GAMP compliant EMS system
Zero Fail HVAC system. Each room with dedicated system for total elimination of cross contamination risks
Visitor corridor allowing full visibility of production floor and technical floors below and above the production floor
One way flow for personnel and material
CCTV system with high resolution for all production rooms
Temperature Controlled warehouse with monitoring system
Cold Stores with monitoring system

Technical Aspects washing, Sterilization& Depyrogenation:

VHP sterilization capability
Steam Sterilization capability
Dry Heat Depyrogenation capability
WFI as only water quality r used for pre rinsing and final rinsing

Technical Aspects Filling line:
Our Bausch& Stroeble filling line can handle ampoules and vials:

2ml and 5 ml ampoules are available formats
2ml, 15ml, and 20 ml vials are available formats
Filling line and all surrounding filling area are Class A laminar Flow zones
Filling line with RABS
Glass particle detection system on filling line before filling point
Automatic In process weight check
24/7 online particle monitoring system on all critical points

Technical Aspects Lyophilizer
Our freeze drier is lyomax 40 from IMA Edwards:

ALUS system integrated
RABS for the loading/unloading zone
Automatic SIP/CIP system
Total shelf area of 40 square meters
Up to 74,000 20 ml vials in one cycle
600 L of drying capacity
Freezing down to -75 °C

Technical Aspects Formulation
Pre sterilized Single use mobius milipore system is used for product formulation:

Batch sizes from 20 liters up to 500 liters
Pre and post filter integrity testing
Dual 0.2 micron filters prior to filling
Technical Aspects Formulation

Technical Aspects identification, inspection& labeling
Our system of identification and handling leaves no margin for product mix up or wrong label, 100 percent automatic physical inspection for all produced containers:

Invisible Data Matrix identification on the bottom of each container
Fully automatic Seidenader inspection machine
Labeling machine with camera system to match data matrix and label data

Technical Aspects QC laboratories
Our 600 square meter laboratory which is in the process of accreditation by WHO is equipped with high end testing equipment:

HPLCs, GC, FTIRs, LPC are few of our available testing equipment
Microbiology lab including Class B sterility laboratory equipped with biosafety cabinets