Arwan incorporates the quality by design concept in its facilities, not only of layouts and buildings, but also of machineries and their tailor-made accessories, equipment and all other involved elements. It assures safe, effective drug supply to our customers, while maintaining flexibility to improve on manufacturing quality performance as needed.

Our formulations and manufacturing processes are designed and developed to ensure a predefined quality.

Arwan’s facility layout is an integrated design that satisfies process requirements, personnel flow, materials flow, equipment layout implementation as well as operational and maintenance access requirements.

At Arwan, special and in certain situations unique measures have been incorporated into our designs and systems to ensure the following:

1 - Zero % Cross Contamination

  Arwan introduced a unique technology in the Middle East for the manufacturing of injectable products using the Mobius Single Use Mixing System from Millipore France, which delivers an advanced and highly reliable technology for the mixing and preparation of solutions for injectable products, eliminating the hazards of cross-contamination.

2 - Zero % Contamination

  Zero % contamination is guaranteed through compliance with very strict gowning procedures, ensured by the use of Tyvek full spectrum clean room garments from DuPont (UK), which create an excellent barrier to non-viable and viable particles. Furthermore zero % contamination is guaranteed by three levels of changing rooms with multiple stages and dual access, special in and out “pass through chambers” for materials, the exclusive use of water-for-injection at all production phases even washing, in addition to the HVAC systems.

3 - Ultra Cleanroom Conditions

 

The cleanroom at Arwan is maintained in an Ultra Clean condition through the installation of HEPA filters covering 100% of the cleanroom ceiling area, in addition to over 400 air exchanges  per hour with unidirectional air flow and an air speed maintained at 0.45m/s + 20% (0.36m/s to 0.54 m/s).

Consequently, the count per 1m³ of nonviable particles is maintained at <100 for 0.5µm size and at <1 for 5.0µm, and at <1 CFU for viable particles (classification of areas is designed as per EN ISO 14644-1 and US FDA/EMEA guidelines). Continuous monitoring is performed by the Environmental Monitoring System, and real-time data is recorded and attached to the Batch Manufacturing Records.

4 - Glass-Free Ampoules and Vials

 

Prior to filling, highly sensitive pre-filling cameras reject any ampoules/vials that contain glass particles.

Furthermore, and to minimize the percentage of broken ampoules/vials in the pyrogenation tunnel (temp 280°C) which might result from sustained high temperature, the validated duration in the tunnel is never exceeded. This is achieved by automatically disposing of all the vials/ampoules once there is any line flow interruption.

5 - 100% Precision and Reproducibility in Filled Volumes, a MUST in Small-Volume Injectables

 

Filling volume precision is guaranteed by a top-of-the-line filling machine, procured from Bausch and Strobel, which is characterized by highly accurate nozzles. Filling volume precision is further ensured by random on-line weighing of filled ampoules/vials.

6 - Zero % Counterfeits and Mislabeling

 

Reacting to the ongoing worldwide alerts of counterfeits and their negative impact on the health and wellbeing of patients, we at Arwan have designed our products to be counterfeit proof, protecting Arwan’s products against copying or mimicking.

A special Data Matrix is laser printed on the bottom of each and every unit produced at Arwan, giving each unit a unique fingerprint that allows our products to be traceable in case of any doubts or claims. Furthermore, on-line labeling, validated by data read from Data Matrixes by specialized cameras, guarantees that the right information, such as product name, dosage, etc… is printed on the label.

7 - Minimal Human Interference

 

Since humans are the major source of contamination and errors, human interference is minimized at all production stages through the use of automatic machinery that are designed and installed to operate in complete synchrony, forming a fully automated production line with automated handover.

The Building Monitoring System (BMS) controls and records real-time data 24/24, and the Environmental Monitoring System (EMS) controls all environmental parameters to maintain the HVAC system’s effectiveness, 24/24.