How to easy start to produce HGH or peptides freezing dry vials from API raw powders?

peptides

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If you need to produce 15,000-20,000 vials per month,,suggest to fill the vials by manual(The sub-machine is the three functions of adding liquid, semi-plugging and capping,it costs about 15K-70K USD,filling 1200-3800vials per hour, at the starting,more machines means more maintenance jobs )

You will need some beakers, measuring cylinders, 4-5 pipette guns. Look it up on amazon or somewhere. The water used for dissolve the raw powder,you can buy the pure water from supermarket(specific conductance under 1.5 uS/cm), you should choose it carefully. When you amount is big enough, you can buy a pure water machine.


Regarding sanitary conditions, first of all, the room can not have Windows, and the floor is clean. Prepare a super clean table. The room of the freeze-dryer should be ventilated, because the oil pump has a smell.


The most important thing is washing bottles, an ultrasound machine, and an oven. The oven needs to reach 250 centigrade degrees for two hours. Basic endotoxin was absent

These require some basic knowledge of laboratory aseptic operation

Buy one set 1 square mater freeze-drying machine (1.5x1.5x2 meters in size ), about 30,000 USD, and flow with a vacuum pump ,you can do the pre-cooling, freeze-drying, vacuum plug in one operation , it needs 24-36 hours, out of about 5,000 bottles.

The rest is gloves, alcohol ,caps pressing forceps(4-5 pcs) and all that stuff .
 
We supply Active Pharmaceutical Ingredients (API) in a form that allows them to be filled and finished to produce the desired dosage form.

Custom APIs

We can utilize its GMP capabilities to produce client-specific APIs under contract, ranging from reagent grade to those suitable for therapeutic use.

Human Growth Hormone (hGH/hST) - Human Somatropin

We have considerable expertise in the manufacture of human somatropin (hGH/hST) that allows the company to efficiently produce commercial quantities. The API product meets the European Pharmacopoeial specifications.

GMP Production and Quality System

With a fermentation capacity of 2X100 L and batch sizes up to 400 g, our production facility houses all the necessary equipment and services for the fermentation, midstream processing, purification and formulation of recombinant therapeutic proteins. For containment purposes areas where genetically modified organisms are present, such as fermentation, midstream process, protein refolding, wash area and liquid waste room, are all Grade D negative pressure (-15 Pa and 30 Pa). The chromatography suite, formulation, dispensing and solution preparation rooms are all Grade C (+ 30 Pa) in order to protect the product. The final filtration step occurs under a Grade A Laminar Flow Unit. An experienced QA and QC team has put in place a robust quality system enabling the company to hold a cGMP-license for production of therapeutic proteins for human use.
 
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