Dr. Edwin Medilabs Pvt. Ltd.
DEMLDEMLDEML
(M) : +91 8427243000
contact@bidubiotech.com
Sector-118, S.A.S Nagar Mohali, Punjab (IN) 140301
DEMLDEMLDEML

Business

CONTRACT MANUFACTURING EXPERTS

Parenteral Manufacturing Experts

Using WHO-GMP, we offer clinical & commercial-scale solutions for all your aseptic/parenteral manufacturing needs. Our quality processes, experienced staff, state-of-the-art equipment, advanced technology and modem facilities provide exceptional results for you.

Reliable solutions
Our team works with single use systems (SUS) to streamline and facilitate the manufacturing of your project, while mitigating the risk of cross-contamination. Trained and experienced with SUS, we have implemented a series of SUS best practices and can quickly determine which clients will most benefit from this technology. With SUS, we are often able to reduce pharmaceutical manufacturing and process development times, enabling more flexibility in process design to help lower capital costs. Included in our SUS platform are a Pall wand mixer and a 100 L, 200 L, and 500 L Mobius jacketed system.
Vial Filling: Liquid and Lyophilized
Our automated Bausch & Stroebel KSF1025 filling line can support clinical and commercial WHO-GMP sterile liquid and lyophilized vial filling from small scale through high volume from 0.2 ml to 200 ml.
Terminal Sterilization
To provide optimal sterility in the pharmaceutical manufacturing process, we have the capability of terminally sterilizing vials ranging from 2R to 5OR.
Labeling and Packaging
Tertiary packaging services and custom kitting capabilities available via our Heidelberg® SPEEDMASTER XL-VIII fully automated machine. Whether products are for clinical trials or the commercial market, we identify efficient integrated packaging and distribution solutions for you
Storage and Distribution: WHO-GDP, WHO-GSP, WHO-GPP, WHO-GTDP complied warehouses
WHO-GMP operations support pharmaceutical packaging, returns, quarantined and controlled substances. Our secure warehousing and processes mitigate risks to product safety, identity, strength, purity, and quality. To avoid temperature excursions that can compromise product integrity, we offer validated temperature monitoring and WHO-GMP warehouse management for your materials in a variety of conditions, including: Ambient storage: +15°C to +30°C. Refrigerated storage: +2°C to +8°C. Frozen storage: -15°C to -25°C. Ultra-low frozen storage: -70°C to -90°C. Controlled substance storage, Schedule III-V

OUR PACKING QUALITY

Pharmaceutical Packaging Grade
Just like pharmaceutical companies, end user also demand safe and high-quality packaging for the medication they take. That’s why at DEML, the wide range of packaging films offered that includes rigid PVC Blister Film , PVC/PVAC films, Alu-Alu laminates, and Triplex films to pack the pharmaceutical products in the best possible way, which protect the products against environmental conditions and microbial contamination, and reduce the waste.
1. Rigid PVC Film (Blister Packaging)
Sound health is always packed in non-toxic and chemical-free foods and pharmaceutical drugs. For the best packaging, DEML manufactures the excellent rigid PVC film leveraging pharma-grade raw materials and latest calendaring process. The films are manufactured under controlled environment as per current GMP norms and comply with all the food and pharma packaging regulations. The modern packaging solution by DEML ranges from 50 to 700 microns and require less fuel in manufacturing and transport as opposed to metal, glass or other materials. That’s increasing its usage and demand in the packaging across the world.
2, PVC / PvdC
In tropical regions, the hygroscopic sensitive products packaging need to be of high quality. PVdC coated PVC films manufactured by DEML are considered as best for the blister packaging due to the coating over rigid PVC films. The PVdC coating of optimum thickness on one side of the packaging minimizes the gas and moisture permeability. The thickness of PVC ranges from 200 to 350 microns with coating GSM 20, 40, 60,90 and 120 GSM to suit the different pharma and food packaging requirements. Also, PVdC coated PVC film is produced as per current GMP norms and in compliance with pharmaceutical packaging regulations.
3. Alu-Alu Laminates (Cold Forming Blister)
The unmatched quality of Alu-Alu laminates was developed and manufactured at DEML to provide the best barrier protection to the pharmaceutical packaging from oxygen ingress, moisture ingress, aroma, and lights. The use of Aluminium as a core material and being an inert and most barrier material ever defined is the main advantage of the cold forming blister because of the high resistance to water and oxygen; that ensures top-grade quality, fracture-free cavity and de-lamination resistance for the longer run.
4. Triplex - PVC | PE / PVdC
Some sensitive or hygroscopic pharmaceutical products need a high level of protection against moisture and oxygen where conventional PVC or PVdC films won’t work. That’s where triplex (PVC/PE/PVdC)—the best blister film for medicines—packaging is more favourable, DEML’s triplex film is manufactured by laminating PVC film with PE layer followed by PVdC coating on it, where all the operations like- calendaring, lamination and coating are done under one roof in a controlled environment.

QUALITY PROCESSES WITH EXCEPTIONAL RESULTS

From technology transfer to product delivery, and development to commercialisation, you will have access to broad capabilities tailored to your specific needs.
Our capabilities include:
Aseptic processing
Biologics and small molecule manufacturing
Controlled substance manufacturing
Formulation volumes up to 2,000,000 L
High-speed filling with washer, depylrogenation tunnel and capper with 100% automated fill weight checks
Commercial-scale lyophilisation with automated loading/unloading and frozen shelf loading
Single-use-systems, or product dedicated process equipment
High-speed packaging with serialization and full aggregation
Automated labeling with vision system

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