| HS Code | 152237 |
| Product Name | Combined Swine Erysipelas and Pasteurella multocida Vaccine, Inactivated Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Product Type | Combined inactivated bacterial vaccine |
| Antigen Composition | Inactivated Erysipelothrix rhusiopathiae and inactivated Pasteurella multocida |
| Target Species | Swine |
| Primary Indications | Active immunization of pigs against swine erysipelas and pasteurellosis |
| Vaccine Format | Veterinary grade API |
| Dosage Forms Available | Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Route Of Administration | Parenteral for injectable forms; oral administration for oral dosage forms |
| Storage Conditions | 2°C to 8°C, protected from light |
| Shelf Life | 18 months from manufacturing date when stored as specified |
| Withdrawal Period | Zero days for inactivated vaccine when used according to label |
As an accredited Combined Swine Erysipelas and Pasteurella multocida Vaccine,Inactivated Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Each sealed container holds 100 g of veterinary-grade combined swine erysipelas and Pasteurella multocida inactivated vaccine API for pharmaceutical dosage forms. |
| Container Loading (20′ FCL) | 20' FCL container loading of inactivated swine vaccine API, sealed and temperature-controlled, with secured pallets for tablets, injections, or powders. |
| Shipping | This veterinary vaccine API requires temperature-controlled shipping to maintain stability and potency. Ship in insulated containers with validated cold packs or dry ice, depending on specifications. Ensure compliance with international biological material regulations, use tamper-evident seals, clear labeling, and expedited delivery to minimize transit time and integrity risks. |
| Storage | Store at 2–8°C in a cool, dry place, protected from light and moisture. Do not freeze. Keep container tightly sealed to prevent contamination. Avoid temperature fluctuations and excessive heat. Use before expiration date. For all dosage forms—tablets, injections, capsules, powders, granules, premix, solutions—follow manufacturer’s cold-chain handling and discard if damaged or discolored. |
| Shelf Life | Shelf life is typically 24 months when stored at 2–8°C, protected from light, and not frozen. |
In grow-finish swine production, the combined inactivated Erysipelothrix rhusiopathiae and Pasteurella multocida antigen concentrate is formulated into an aqueous aluminum hydroxide adjuvanted suspension for intramuscular administration. The industry compliance baseline for this presentation includes USDA 9 CFR 113.100 general requirements for killed bacterial vaccines and Ph. Eur. monograph 0064 for swine erysipelas vaccine (inactivated), with batch safety and potency testing performed according to USDA 9 CFR 113.100 and sterility confirmed by 9 CFR 113.26 or Ph. Eur. 2.6.1. The formulation addition ratio is not expressed as a fixed weight percent of the API alone because antigen mass is standardized by relative potency assay; however, the two inactivated antigen concentrates are typically combined at a 1:1 to 1:3 volume ratio, diluted into phosphate-buffered saline to final dose volume, and adsorbed onto 10–20% v/v aluminum hydroxide gel. The downstream production process begins with stirred-tank bioreactor cultivation of each bacterial strain to a pre-inactivation concentration of 108–109 CFU/mL, followed by formaldehyde inactivation at 0.2–0.3% w/v for 24–48 h at 36–38 °C. The killed cultures are concentrated and washed by tangential flow filtration using a 100 kDa MWCO membrane, then mixed under low-shear agitation for 60–90 min to complete adjuvant adsorption. Aseptic filling into single-dose 2 mL syringes and multi-dose 20 mL, 50 mL, and 100 mL polyethylene vials constitutes the terminal finished product type; final container integrity testing follows ISO 13408-5 aseptic processing guidance.
| Jurisdiction | Standard designation | Test endpoint | Relevance to combined API |
|---|---|---|---|
| United States | USDA 9 CFR 113.100 | Killed bacterial vaccine general safety, potency, reagent purity | Batch release for E. rhusiopathiae and P. multocida bacterin |
| European Union | Ph. Eur. 0064 | Swine erysipelas vaccine (inactivated) potency and safety | Potency standardization for erysipelas component |
| European Union | Ph. Eur. 0062 | Vaccines for veterinary use general monograph | General analytical and label requirements |
| United States | 9 CFR 113.26 | Sterility of biological products | Finished product sterility |
| International | Ph. Eur. 2.6.1 | Sterility test method | Alternative sterility test method for final containers |
The lyophilized powder route is selected for distribution into regions where cold-chain stability at ambient temperatures is required for stockpiling or where multi-dose vials must be reconstituted immediately before mass vaccination. Dry granule tableting or encapsulation for oral administration is not used because gastric degradation of bacterial antigens and the absence of an approved mucosal adjuvant prevent release of a compliant finished product. The critical process parameter in this downstream application is the glass transition temperature of the maximally freeze-concentrated solution (Tg′), which for the trehalose-mannitol-gelatin matrix containing inactivated bacterial cell bodies is typically maintained between -35 °C and -25 °C; primary drying shelf temperature must remain below the collapse temperature to avoid cake shrinkage and loss of antigen activity. The formulation addition ratio before lyophilization is controlled as follows: antigen concentrate 15–30% v/v after diafiltration, trehalose dihydrate 4–6% w/v, mannitol 2–4% w/v, and hydrolyzed gelatin 0.5–1.5% w/v in Water for Injection. The downstream process uses a lyophilizer with shelf surface temperature uniformity better than ±2 °C, freezing to -45 °C at 0.3–0.5 °C/min, primary drying at -30 °C shelf temperature with chamber pressure 50–100 mTorr for 18–26 h, and secondary drying at +25 °C for 4–6 h until residual moisture is below 2% w/w. Compliance for this terminal dosage form includes USDA 9 CFR 113.100 and Ph. Eur. 5.2.2 for freeze-drying process validation, while sterility is confirmed by 9 CFR 113.26 or equivalent Ph. Eur. 2.6.1. Terminal finished products include 5-dose, 10-dose, and 50-dose Type I glass vials with rubber stoppers, each requiring reconstitution with sterile phosphate-buffered saline to a final dose volume of 2 mL.
For sow and gilt vaccination programs targeting maternal antibody transfer, the inactivated API is converted into a water-in-oil emulsion that prolongs antigen release at the injection depot. The aqueous antigen phase, containing the combined inactivated bacteria and aluminum hydroxide at 10–15% v/v, is added at 45–55% v/v to a light mineral oil continuous phase containing 40–50% v/v mineral oil and 5–8% v/v mannide oleate emulsifier. The downstream process requires a high-shear rotor-stator mixer operating at 6,000–8,000 rpm for 10–20 min, followed by droplet size analysis under laser diffraction; droplet mean diameter below 1 µm or above 5 µm triggers batch rejection because submicron droplets may increase systemic adjuvant exposure and coarse droplets are associated with injection-site granulomas. Viscosity is measured at 25 °C using a Brookfield rotational viscometer and controlled to 20–60 mPa·s. Industry compliance for this route includes USDA 9 CFR 113.100 killed bacterial vaccine requirements, 9 CFR 113.26 sterility, and Ph. Eur. 0062 vaccines for veterinary use; emulsion stability is evaluated by centrifugation at 3,000 × g for 30 min and storage at 37 °C for 30 d with no phase separation greater than 5%. Terminal finished product types are 20 mL and 50 mL multi-dose vials and pre-filled 2 mL syringes for pre-farrowing sow vaccination.
Where regional veterinary biologics authorizations permit polyvalent presentations, the combined inactivated API is blended with additional porcine bacterin or toxoid concentrates to reduce the number of injections per animal. No universal addition ratio exists for polyvalent blending because the final antigen load is expressed by relative potency per dose; the combined API typically contributes 30–70% v/v of the final bulk, with the remaining volume allocated to additional antigen concentrates, adjuvant, and stabilizer. The downstream process is carried out in stainless-steel mobile tanks with bottom-mounted magnetic impellers under 50–100 rpm agitation for 30–60 min at 4–8 °C, avoiding high-shear mixing that can desorb aluminum hydroxide-bound antigens. Batch-to-batch variance in antigen concentration must be monitored by ELISA antigen mass quantification before blending, and the final bulk is held for 24–48 h at 2–8 °C to allow complete adjuvant adsorption. Compliance for this downstream route includes USDA 9 CFR 113.100 and Ph. Eur. 0062; when the combined API is used in autogenous polyvalent products, additional authorization under national veterinary biological product regulations for autogenous vaccines may apply. Terminal finished product types are polyvalent aqueous suspensions in 50 mL, 100 mL, and 250 mL multi-dose bottles.
The API is used as a pre-standardized inactivated antigen premix for veterinary biologics manufacturers producing custom autogenous bacterins from farm-specific E. rhusiopathiae and P. multocida isolates. In this downstream route, the formulation addition ratio of the API to final autogenous product is determined by the prescribing veterinarian and the manufacturer's potency assay; working additions often fall between 10% and 40% v/v, with aluminum hydroxide gel at 10–15% v/v and phosphate-buffered saline diluent making up the balance. The downstream production process requires inactivation verification by two blind passages in appropriate culture media, sterility testing by 9 CFR 113.26 or Ph. Eur. 2.6.1, and formalin residual measurement by HPLC with a limit of 0.2% w/v free formaldehyde. The finished autogenous bacterin is filled into 100 mL or 250 mL high-density polyethylene bottles and labeled with a maximum period of administration; such products are typically restricted to the specific farm or production system from which the isolates were obtained. Published data for this specific configuration is limited because autogenous products vary by isolate; therefore, the addition ratio and potency release criteria are lot-specific rather than fixed.
High-throughput swine vaccination using needle-free jet injectors imposes narrow limits on particle size and viscosity, because clogging of the injector orifice and incomplete dose delivery are the principal production-floor failure modes. For this application, the combined inactivated antigen concentrate is formulated as a preserved aqueous solution or fine suspension with reduced aluminum hydroxide content, typically 5–10% v/v, and the addition ratio of the API is adjusted to 20–35% v/v of the final bulk; the remainder is phosphate-buffered saline, 0.5–1.0% v/v polysorbate 80, and 0.05–0.1% w/v 2-phenoxyethanol as preservative. The downstream process includes filtration through a 10 µm polypropylene depth filter to remove aggregates, viscosity measurement at 20 °C with a target below 15 mPa·s, and filling under aseptic conditions into 20 mL or 100 mL multi-dose bottles. Terminal finished product types are ready-to-use solutions for needle-free intramuscular or intradermal injection devices; compatibility with the specific device model must be validated because jet injector shear stress can exceed 500 s-1 and may reduce antigen integrity if aggregation is not controlled. Compliance includes USDA 9 CFR 113.100 and 9 CFR 113.26, with additional device-specific performance validation required by the injection equipment manufacturer.
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| Attribute | Method or principle | Acceptance criterion | Reference standard |
|---|---|---|---|
| Sterility | Membrane filtration or direct inoculation | No growth in thioglycollate and soybean-casein digest media | 9 CFR 113.26; Ph. Eur. 2.6.1 |
| Inactivation completeness | Two-passage enrichment and culture | No viable target organism recovered | Product-specific; 9 CFR 113.119/9 CFR 113.70 |
| Identity | Slide agglutination or ELISA | Specific reaction with reference antisera | Manufacturer standard operating procedure |
| Relative potency | ELISA or vaccination-challenge | Meets approved release value | 9 CFR 113.119/9 CFR 113.70 |
| Residual inactivant | HPLC or colorimetric assay | Not exceeding approved residue limit | Marketing authorization file |
| Homogeneity | Optical density or nephelometry after inversion | Uniform antigen distribution in the withdrawn sample | Manufacturer in-process specification |
| Parameter | Combined inactivated API | Live attenuated *Erysipelothrix* vaccine | Separate monovalent bacterins |
|---|---|---|---|
| Reversion risk | Absent | Present, although attenuated | Absent |
| Antigenic composition | *E. rhusiopathiae* + *P. multocida* | *E. rhusiopathiae* only | One genus per product |
| Adjuvant strategy | Aluminum hydroxide or oil-in-water emulsion | Generally non-adjuvanted or minimally adjuvanted | Aluminum hydroxide or oil-in-water emulsion |
| Dosage-form flexibility | Liquid suspension, lyophilized powder, coated granules/premix with limitation | Freeze-dried live culture | Liquid suspension |
| Cold chain | 2–8 °C; lyophilized powder requires low moisture | 2–8 °C or lyophilized | 2–8 °C |
| Handling risk | No live organism exposure | Requires care to avoid environmental contamination | No live organism exposure |
