cgmp manufacture api reactor hastelloy
Manufacturing - Siegfried
cGMP Clinical & Commercial Manufacturing. Few decisions in pharmaceutical operations are as critical as selecting the right cGMP Contract Manufacturer for your company's Active Pharmaceutical Ingredient (API). APIs manufactured to cGMP standards for commercial sale must meet stringent requirements for identity, strength, quality and purity. 2 cGMP pilot plants with 11 multipurpose reactors from 100 L to 2 800 L (total capacity of 12 m³) Temperature range: -15/+150°C (hastelloy reactor: -80/+200°C) 3 finishing rooms (agitated filter dryers, filters, dryers, milling and sieving equipments)
[Leave Message]
Contract Manufacturing - UBE INDUSTRIES,LTD.
• cGMP Kilo Lab facilities. • Up to 50L glass reactor vessels. • Temperature range -20ºC to 150ºC. • Hastelloy ® filter drier technology. • Pressure hydrogenation. • Production up to 10kg scale. Pilot Plant • Secure cGMP Pilot Plant facilities. • Glass-lined reaction vessels up to 250L volume. Manufacturing. Manufacturing your custom and complex Active Pharmaceutical Ingredients (API) requires preeminence and scale. Backed by an excellent compliance history and track record, Anvi’s API Manufacturing offering supports the commercial cGMP manufacturing of High Potent APIs, Bulk drug APIs, as well as the production of raw materials and starting materials.
[Leave Message]
Cambrex increases pilot scale API capacity
Our bulk cGMP API facility located in West Deptford, New Jersey . houses hastelloy and glass-lined reactor trains ranging in capacity 19 to 7,500L. ... Riverside is equipped to manufacture parenteral grade APIs (microbial/endotoxin environmental controls) ... The 4,500 sq. ft. production area will operate to an occupational exposure limit (OEL) down to 0.1µg/m³ and will have a total reactor capacity of 2,200 gallons, consisting of a range of 200, 500 and 1,000 gallon glass and Hastelloy vessels to manufacture batches from 50 to 300kg.
[Leave Message]
cGMP API Manufacturing – Eurocare - Pharm
cGMP API Manufacture. At UBICHEM Pharma Services, we have regulatory approval for cGMP manufacture of APIs and intermediates on lab to pilot plant scale, from preclinical through to commercial supply; meeting the needs of your development programmes. cGMP API Manufacturing. Dalton is a leader in the development and manufacture of complex cGMP Active Pharmaceutical Ingredients (APIs). Our skilled scientists and recently updated and renovated cGMP development and manufacturing facility support the Drug Discovery process through API Synthesis for all stages of pre-clinical and clinical trials as well as small scale commercial manufacturing.
[Leave Message]
cGMP API Manufacture | Ubichem
Multiple glass-lined 300 gallon reactor trains, with a total primary reactor capacity of 1,500 gallons Flexible cGMP plant can produce up to ~100 Kg lots of potent / cytotoxic drugs New 0.4 m² Hastelloy C Nutsche filter dryer with containment glove box isolator, as well as a multitude of portable Aurora filters (Hastelloy C and Stainless Steel) 100 liter glass reactor in Howorth full containment fume booth; 100 liter Hastelloy C hydrogenation reactor (50 psi) Broad processing temperature range – (-)80ºC to (+)200ºC; Certified to handle compounds down to 0.10 ug/m³ – SafeBridge Category 4 capable; Kilo-scale non-cGMP …
[Leave Message]
Contract Development and Manufacturing of Highly Potent …
development & analysis. API scale-up and cGMP manufacturing is provided in its segregated production facilities for high potency materials. Drug product formulation development and small scale cGMP manufacture is also provided at Zofingen in Siegfried’s purpose built containment facility opened in 2012. Coupled with existing Regis can scale up and manufacture initial GMP batches from 50g to 2kg. Transition easily through Phase 2 and all the way to commercial manufacturing with Regis' CGMP Reactor suites capable of 100 kg per batch. For your potent APIs, commission Regis' new Potent Compound Suite for the development and CGMP production up to about one kilogram per ...
[Leave Message]
8,600 Liter Active Pharmaceutical Ingredient (API) Plant ...
manufacture, nor aspects of protection of the environment. These controls are inherent ... API Starting Materials normally have defined chemical properties and structure. The company should designate and document the rationale for the point at which production of API DEVELOPMENT SERVICES From route selection and optimization through to cGMP manufacture, Aesica’s team of experienced Ph.D chemists have the skills and expertise to deliver all your process development and scale-up requirements. We focus on providing a safe, robust, scalable, cost-effective process for your API.
[Leave Message]
Pfanstiehl - Kilo Lab Manufacturing
Phoenix Equipment Corporation has this used active pharmaceutical ingredient (API) plant immediately available. This pilot API plant has 20 reactors in 7 segregated processing suites for GMP manufacturing. Broad range of reactors range in capacity from 10 gallon to 500 gallon (40 – 2000 liters), constructed from Hastelloy (12) and GLCS (8). We conduct cGMP manufacturing of API's from grams to multi-kilos. Our R&D and cGMP manufacturing areas can support reactor sizes up to 300L. Custom Synthesis of Small Molecules and biopolymers is carried out in our modern cGMP API manufacturing facility. Our two clean API suites are rated at Class 10,000 (Class C).
[Leave Message]
Q 7 Good Manufacturing Practice for Active Pharmaceutical ...
20 litre, 350 bar, 350°C, Hastelloy, electric lift, easy acces swing-out mechanism 100 litre, 60 bar hydrogenation reactor, Hastelloy, cGMP, wall mounted Pressure reactors with large volumes are used for many different processes in chemical and pharmaceutical industries. The design is therefore often customized. We plan and manufacture · Cambrex increases pilot scale API capacity . 19-May-2017 . Monitoring. The investment to increase reactor capacity by 30% will take place at the company's High Point facility in …
[Leave Message]
API DEVELOPMENT SERVICES
UBE offers total solution of APIs & intermediates manufacture. US-FDA Europe Japan (Manufacturing Approval) 1998: API for human drug (IND) 1998~ Fully validated cGMP site for commercial-scale API manufacturing, SAFC’s Arklow facility features four separate plants, and has a total reactor capacity of over 90,000 L. cGMP, FDA and IMB inspected; 14 glass-lined reactors (250-8,000 L) 5 stainless steel reactors (4,000-8,000 L) 1 Hastelloy ® steel reactor …
[Leave Message]
High Potency API and Drug Product Services
A Hastelloy Reactor performs robustly in the harsh fluids inherent these processes. These chemicals are frequently at very high temperature, testing the material’s strength and corrosion resistance, yet a HASTELLOY Reactor is resilient. TITAN Hastelloy Reactors are used in a wide variety of oxidizing and reducing environments. API Manufacturing API Manufacturing Capacity Take a tour through our Newburyport, MA cGMP facility and see our range of Reactors, Driers and Filters.
[Leave Message]
cGMP API Manufacturing from Dalton Pharma Services ...
Manufacture takes place in facilities which include a class 100,000 API lab, Kilo Lab, and a pilot plant with vessels up to 1,600 litre, including a 1,000 litre Hastelloy C reactor capable of operating down to -80°C.Such work is supported by a fully qualified, well equipped … Syngene’s cGMP manufacturing facility is spread across 60,000 sq. ft. We have over 36 reactors ranging from 20L to 3000 L having capacities in SS 316 L, glass lined, Hastelloy. We are equipped with Automated systems like Building Management System (BMS) and Distributed Control System (DCS) to manage facilities.
[Leave Message]
Büchi «pilotclave» Pressure reactors for research and ...
Customized API development and manufacturing services. We are an industry-leading integrated development and manufacturing service provider for small molecule drug substances and their intermediates. Chemistry is core to us. Our track record in producing API and intermediates extends back to the genesis of contract development and manufacturing. If you have questions about GMP API Process Validation, please contact us These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, food, and blood products take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, […]
[Leave Message]
Active Pharmaceutical Ingredients and Intermediates | Lonza
Pilot Plants. Our two main production units are manually controlled, overpressured multi-purpose units. Each reactor is independently ventilated to avoid cross-contamination; the Hastelloy C reactor is particularly useful for running organometallic chemistry – typically lithiations, Grignards or … Regulations help to ensure quality drug products. FDA monitors drug manufacturers' compliance with Current Good Manufacturing Practice (CGMP) regulations.
[Leave Message]
Current Good Manufacturing Practice (CGMP) Regulations …
API & early phase drugs. Remarks. cGMP non-sterile. Facilities: Containment Area 600 L(GL) Reactor x2 800L Glass Lined Reactor Filter Dryer (0.38m 2) Material: Hastelloy C22 equivalent Micronization equipment: Spiral jet mill Multipurpose line Minimum mixing volume 50L Minimum mixing volume 50L Dryer filter capacity: 100L cGMP API Manufacturing. Eurocare is a leader in the development and manufacture of complex cGMP Active Pharmaceutical Ingredients (APIs). Our skilled scientists and recently updated and renovated cGMP development and manufacturing facility support the Drug Discovery process through API Synthesis for all stages of pre-clinical and clinical trials as well as small scale commercial manufacturing.
[Leave Message]