Puqi Qingwang Powder Veterinary Grade API is supplied as a milled botanical active substance for downstream conversion into oral powders, granules, tablets, capsules, premixes, solutions and injectable preparations. In high-density broiler and layer production sites, the powder is converted into a water-dispersible oral powder through a two-stage dry blending sequence that avoids granulation and permits direct farm-side reconstitution. The botanical active substance is milled through a stainless steel hammer mill fitted with a 120-mesh screen at rotor speed 4,800 rpm; milling chamber outlet temperature is held below 60°C to limit thermal degradation of thermolabile polysaccharides. The milled powder is pre-blended with anhydrous dextrose and citric acid in a 500 L V-type mixer at 60% fill volume for 20 min at 15 rpm, then a second blending stage with polyvinylpyrrolidone K30 and colloidal silicon dioxide is run for 10 min. Content uniformity is verified on 10 stratified samples according to USP <905>; the acceptance value is capped at 15.0. Bulk density is maintained between 0.45 g/cm³ and 0.65 g/cm³ to avoid hopper segregation, and wetting time is specified as <30 s for 5 g in 500 mL water at 25°C. The API load in the finished oral powder is 20–50% w/w, with reconstitution at 1.0 g/L drinking water for 3–5 days under veterinary prescription. Compliance for this route references Regulation (EU) 2019/6 Annex II for manufacture of veterinary medicinal products, Ph. Eur. 2.9.5 for uniformity of content, Ph. Eur. 2.2.32 for loss on drying, Ph. Eur. 2.4.8 for heavy metals, and Ph. Eur. 2.8.18 for aflatoxin B1. Unless otherwise noted, the numerical processing parameters in this section are equipment capability values or contract release specifications, not clinical efficacy claims. Terminal product forms are 100 g, 500 g and 1 kg aluminium-composite sachets for oral solution reconstitution, and 5 kg bulk pouches for farm dosing pumps.

What Limits Granule Integrity in Swine Feed Premix Lines?

In swine feed integration, the powder is rarely used as-is; it is converted into a low-dust granule to reduce metering drift in automated feed dispensing equipment and to limit cross-contamination between production orders. The API is dispersed into a horizontal ribbon mixer with corncob grit carrier at a pre-blend inclusion of 5–15% w/w of the intermediate premix. A granulation binder consisting of sodium lignosulfonate solution at 3% w/w is added at 8–10% of the dry-blend mass. The wet mass is passed through a 1.5 mm screen, dried in a fluid-bed dryer at 60–70°C until loss on drying is below 5.0% w/w by Ph. Eur. 2.2.32, and re-sieved to retain particles between 0.5 mm and 1.5 mm. Finished complete-feed inclusion is set at 0.5–1.0 kg per metric tonne, with a coefficient of variation below 5.0% after 10 min mixing in a 2.0 m³ paddle mixer at main shaft speed 30 rpm. Dust fraction below 0.25 mm is kept under 10% w/w to prevent bucket elevator carryover; previous-batch carryover is monitored by tracer studies and controlled below 0.5% of the prior medicated feed. Compliance references EU 183/2005 Annex II for feed hygiene, Regulation (EU) 2019/4 for medicated feed intermediates, Directive 2002/32/EC for botanical impurities and heavy metals, and ISO 6497:2002 for sampling methodology. Terminal products include 1 kg, 5 kg and 25 kg granulated premix bags with inner polyethylene liner and pelleted complete swine feed after steam conditioning at <75°C for <30 s.

Companion Animal Tablet and Capsule Filling Operations

Compressed tablet and hard gelatin capsule dosage forms for companion animal pharmacies require narrower particle size control and more rigorous moisture limits than feed-grade powders. The API is hammer-milled to a d90 below 150 μm and pre-dried in a vacuum tray dryer at 50°C when ambient relative humidity exceeds 60%; residual moisture above 5.0% w/w has been observed to cause picking and sticking on rotary tablet punch faces when press speed exceeds 40 rpm. Direct compression formulations are loaded with the active powder at 25–40% w/w, microcrystalline cellulose PH102 at 35–55% w/w, croscarmellose sodium at 2–5% w/w, and magnesium stearate at 0.5–1.0% w/w. Tablet compression runs on a 27-station rotary press at 60–100 N hardness, with friability testing according to USP <1216> and acceptance below 1.0%. Disintegration is tested according to Ph. Eur. 2.9.7 in water at 37±2°C, with complete disintegration within 15 min for uncoated cores. Capsule filling is performed on a dosator-type capsule machine using size 0 or size 1 hard gelatin capsules; fill weight variation is checked with USP <905> and Ph. Eur. 2.9.5. Film coating, when specified, uses hydroxypropyl methylcellulose 6 cP to a 3% weight gain. Compliance references include Regulation (EU) 2019/6 Annex II, Ph. Eur. 5.1.4 for microbiological quality, ICH Q7 for active substance GMP, and Ph. Eur. 2.2.32 for loss on drying. Because published stability data for this specific botanical powder in tablet form is limited, formal stress testing at 40°C/75% RH is required before assigning retest intervals. Terminal product types are 100 mg, 250 mg and 500 mg scored tablets and size 0/1 capsules in polyvinyl chloride-aluminium blister packaging.

When injectable solutions are developed from the aqueous extract of the milled powder, the production route shifts from simple blending to aseptic filtration and depyrogenation. Only powder lots that pass bacterial endotoxin testing according to Ph. Eur. 2.6.14 with a limit of <0.5 EU/mg and sterility testing according to Ph. Eur. 2.6.1 are cleared for parenteral work. The powder is dissolved in Water for Injections at 40±2°C, adjusted to pH 5.5–7.0 with dilute sodium hydroxide, and clarified sequentially through 0.8 μm and 0.45 μm membrane filters. The clarified solution is passed through a 10 kDa ultrafiltration cassette; flux decline below 20 L/m²/h during this step has been associated with inadequate prefiltration and can increase downstream endotoxin risk. The retained filtrate is standardised to 50 mg/mL dried extract equivalent and made isotonic with 0.9% w/v sodium chloride. Terminal sterilisation is not applied because of thermal sensitivity; the solution is sterile-filtered through a 0.22 μm PVDF cartridge filter and aseptically filled into Type I glass vials depyrogenated at 250°C for 30 min. Filter validation follows PDA Technical Report 26 using Brevundimonas diminuta challenge at ≥10⁷ CFU/cm². Aseptic filling occurs under Grade A with Grade B background according to EU GMP Annex 1 (2022), and in-process hold time is limited to 24 h at 2–8°C. Published long-term stability data for this specific extract form is limited; therefore, real-time stability batches are mandatory. Terminal product types are 50 mL and 100 mL multi-dose injectable solutions for veterinarian-administered use in cattle and swine.

When the Powder Is Loaded into Medicated Feed for Ruminants

In ruminant production, the powder is introduced into compound feed or mineral premixes only after the particle size distribution is matched to rumen residence time and the fibre content is controlled to avoid pellet die blockage. The milled API is first blended with limestone or wheat bran carrier at a ratio of 1:9 to form a working premix, which is then metered at 10.0 kg per metric tonne of complete feed. The final active powder concentration in the complete ration is maintained at 0.5–2.0 kg/metric tonne; the upper limit is reserved for short-duration therapeutic rations under veterinary prescription. Mixing is carried out in a paddle mixer with a working volume of 2.0 m³ for 10 min at main shaft speed 30 rpm; mixer profile testing uses methyl violet tracer and acceptance is set at a coefficient of variation below 10%. Pellet die blockage has been observed when coarse lignified particles exceed 1.5 mm and conditioner moisture is below 12%; therefore, the premix is passed through a 1.25 mm screen before feed mixing. If the ration is pelleted, steam conditioning is limited to <75°C for <30 s to reduce thermal loss. Compliance references include Regulation (EU) 183/2005 Annex II, Directive 2002/32/EC for heavy metals and botanical impurities, ISO 6497:2002 for sampling, and Regulation (EU) 2019/4 for official controls on medicated feed intermediates. Terminal finished product types are 25 kg ruminant concentrate premixes, 500 g veterinary oral granules, and complete pelleted rations.

What Prevents Nozzle Blockage in Hatchery Spray-Dried Concentrate Production?

Day-old chick hatcheries require a reconstitutable concentrate that dissolves rapidly in cold drinking water without plugging nipple drinker lines. The powder is wet-mixed with maltodextrin DE10 at 30% w/w active powder loading and deionised water to a total solids content of 20–25% before spray drying. Spray drying is performed in a co-current disc atomiser with inlet temperature 160–180°C, outlet temperature 70–80°C, and feed rate adjusted to achieve final moisture below 5.0% w/w. Insoluble fibre fractions above 150 μm in the feed liquid can obstruct rotary atomiser slots, causing particle size drift and increased wall deposition; the liquid is therefore passed through an in-line 150 μm strainer before atomisation. The spray-dried powder is agglomerated to 150–300 μm and tested for wetting time; acceptance is <60 s for 2.0 g in 200 mL water at 20°C. Reconstitution at the hatchery is specified at 2.0 g/L in drinking water for the first 3–5 days post-hatch. Compliance records reference EU 183/2005 feed hygiene requirements, Regulation (EU) 2019/4 for intermediate feed products, and Ph. Eur. 5.1.4 for the non-sterile microbial limit; total aerobic microbial count is controlled below 10⁴ CFU/g, and Escherichia coli is absent in 1 g. Terminal products include 500 g and 1 kg spray-dried sachets and bulk 10 kg foil-lined cartons for automated hatchery dosing systems.