one of two manufacturing facility’s at Rechon, is a cGMP facility and located in Limhamn. The Bulk Production surroundings consists of cleanroom in various grades, from grad A-B. Around 40 people work in the department, and part of the department work in a two shift schedule.
The main focus in the Bulk production department is manufacturing of aseptic solutions for injection for both commercial scale batches, and also for small scale development and clinical trial bathes according to below.
- Non-GMP early development material
- Manufacturing of clinical trial material
- Manufacturing and filling of finished products according to cGMP
The specialty at Bulk Production are aseptic filling of ampoules, vials, cartridges and pre-filled syringes. Also filling av nasal and oral spray solutions is a part of the manufacturing skills. In the service we include
The Bulk Production department are divided into four areas:
1. Aseptic Cleaning Service
This area includes all cleaning in the manufacturing areas, which consists of cleanroom grade A-D. Also washing garments uses in the clean room and washing all equipment used for the manufacturing. The service also includes purchase of consumables to secure the manufacturing according to cGMP and clothing routines.
2. Compounding and sterile filtration
Capabilities to Compound and Sterile filtrate batch sizes from 1-400 liters. From first clinical batch to the final commercial batch size. The equipment used is single used material or product dedicated e.g tanks/vessels, tubes.
All sampling of raw material takes place in this area as well together with handling all samples from manufactured batches, to be sent to QC lab (internal or external).
Filling of the compounded and sterile filtrered solutions in various filling line depending on the demands and costumer wishes. Different containers and volumes e.g vials, cartidges, syringes and ampoules are all aseptic filled in different sizes from less than 0.15 up to 10 ml. Also filling can be manufactured in spray from 2 to 10 mL.
The filling lines include rinsing machine, sterilization tunnels and filling and sealing. Both for injectables and spray products. For ampoules there are routines for leakage test prior visual inspection.
4. Visual inspection
This has historical taken place in the second of Rechons manufacturing facilitys, the Packaging department. Bur during 2021 this step will be included within the Bulk Production gradually.