Products

OEM Manufacturing of Freeze-dried products
OEM Manufacturing of Freeze-dried products
2019-08-21
OEM Manufacturing of Pharmaceutical Tablets
OEM Manufacturing of Pharmaceutical Tablets
2019-08-22
Show all

OEM Manufacturing of injectable solutions

Spectrum Pharma (SP)  owns advanced aseptic vial processing equipment that is uniquely engineered to outperform. A special emphasis is put on high quality, small scale, and efficient design principles. Special emphasis is put on simplistic, yet robust design, adherence to cGMP guidelines, and quality, not only of the machines, but also of the supporting validation documents. No format/change parts are required. The trayloaders are menu-driven with a PLC-assisted changeover and feature automatic nesting.

Category:

Tags: , ,
Description
  • Equipment that conforms to EU, U.S., and Japanese GMP
  • Oversight of manufacturing of biological products by a manufacturing administrator
  • Contract manufacturing of vial-packaged liquid injectable drugs using sterile manipulation
  • Operations including raw material and material acceptance testing, weighing, formulation, sterile filtration, filling, and inspection processes
  • Automated warehouse and shipping staging area with refrigerated storage to allow temperature control until product shipment

Equipment

Manufacturing of sterile solution in 1 – 1000 ml vials

  • Bausch+Ströbel (Germany) semi-automatic vials washing machine
  • Isolator Isotech (Canada) class A (ISO 4/5) environment ensure vial’s filling under aseptic conditions for heat sensitive products
  • Vials filling and closing equipment Flexicon (Denmark) placed in isolator
  • Sterilization of vials by autoclaving (Fedegari (Italy)) is possible as well.
  • Mean production batch size up to 30000 vials for solutions
  • Production capacity 150 – 300 thousand vials per month.

 

OEM Manufacturing of injectable solutions OEM Manufacturing of injectable solutions

Attention

Spectrum Pharma does not ship to countries, which classify these pharmaceuticals as special controlled or scheduled substances, including but not limited to the United States, Australia, Canada and Europe.

  • – We do not sell any products online.
  • – We do not sale to the public.
  • – We do not ship any products.
  • – We are not directly or indirectly associated with any websites that may engage in selling same or similar products.


Information contained within this website is not a prescription to use and is intended for information purposes only. Our products are made in Europe area and follow local laws accordingly, but FOR EXPORT ONLY. All manufacturing is in accordance with USP or BP Guidelines. Please Note: We are not an online store. We do not sell or ship to the USA, Europe, Australia or any other locations where prohibited. All information contained within this website or in any literature provided is not a prescription to use. Please seek the advise of a physician specializing in Andrology before use.