ARC-Series Maglev Pump-ARC-0200 Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable
- Product Name: ARC-Series Maglev Pump-ARC-0200 Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable
- Factroy Site: Yudu County, Ganzhou, Jiangxi, China
- Price Inquiry: sales10@ascent-chem.com
- Manufacturer: Ascent Petrochem Holdings Co., Limited
- CONTACT NOW
- ARC-Series Maglev Pump-ARC-0200 Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is typically used in formulations when low-shear, high-purity, particulate-controlled conditions and process temperature, pressure, and flow rate must be controlled within specific ranges.
| HS Code | 881547 |
| Product Name | ARC-Series Maglev Pump-ARC-0200 Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable |
| Series | ARC-Series |
| Model | ARC-0200 |
| Product Type | Maglev Pump |
| Grade | Pharma Grade API |
| Primary Application | Tablet / Capsule / Granule / Injection |
| Route Of Administration | Oral & Injectable |
| Pump Mechanism | Magnetic Levitation |
| Intended Industry | Pharmaceutical |
| Compatible Dosage Forms | Tablet, Capsule, Granule, Injection, Oral, Injectable |
As an accredited ARC-Series Maglev Pump-ARC-0200 Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Packaged in one 1 kg sterile, double-lined, sealed pharmaceutical container with protective liner, labeled for oral and injectable API use. |
| Container Loading (20′ FCL) | 20′ FCL container loading: ARC-0200 Maglev Pump, pharma-grade API, palletized, moisture-controlled, compliant for tablet, capsule, granule, oral and injectable production. |
| Shipping | The ARC-0200 is shipped in compliant, tamper-evident, shock-resistant packaging. Temperature-controlled and humidity-monitored where required, with cold-chain options for injectable/oral API. Each shipment includes certificates, safety data, and tracking. Handle under GMP conditions; store per label. Expedited, insured, worldwide delivery available, with documented chain of custody. |
| Storage | Store ARC-Series Maglev Pump-ARC-0200 Pharma Grade API in its original, tightly sealed container at controlled room temperature, 20–25°C (68–77°F), with excursions permitted to 15–30°C. Protect from light, moisture, heat, and contamination. Keep in a clean, dry, well-ventilated, secure area, segregated from incompatible substances. Follow manufacturer labeling, pharmacopeial requirements, and SDS guidance. For oral and injectable use, retain original labeling and batch records. |
| Shelf Life | Typical shelf life: 24 months when stored sealed, dry, protected from light, at controlled room temperature; confirm exact expiry on COA. |
Without a dedicated dry-granulation step, ARC-0200 is incorporated into immediate-release tablet cores only when the final active ratio remains inside the flow and compressibility envelope of the selected filler; pre-processing particle size control is therefore mandatory, with a D90 below 45 µm documented by laser diffraction before batching. If ambient relative humidity exceeds 60%, ARC-0200 is pre-dried in a vacuum oven at 40°C for 4 h, then passed through a 0.5 mm sieve to break soft agglomerates. The formulation addition ratio is maintained at 5.0% w/w to 35.0% w/w of total core mass, so a 200 mg core carries 10 mg to 70 mg active per unit. Above 35.0% w/w, the blend bulk density falls below 0.40 g/mL and tablet weight variability exceeds 2.0% RSD unless the route is switched to dry granulation. When the direct compression route is used, ARC-0200 is pre-blended with lactose monohydrate and microcrystalline cellulose in a 500 L bin blender equipped with an intensifier bar; intensifier speed is capped at 3,000 rpm for 6 min to prevent fines migration, and the flow function coefficient is maintained above 4.5. The blend is discharged into a 45-station rotary tablet press running 60 rpm turret speed with 10 kN precompression and 80 kN main compression; compaction force is monitored continuously with a strain-gauge load cell, and ejection force is kept below 2.0 kN by adding 0.5% w/w sodium stearyl fumarate as lubricant. In-process tests include loss-on-drying at ≤2.0% w/w, bulk and tapped density under USP <616>, and content uniformity on compressed cores. Quality release follows USP <905> for uniformity of dosage units, USP <711> for dissolution with apparatus 2 at 50 rpm, and 21 CFR 211.110(a) for in-process blend uniformity. Terminal product types are biconvex round film-coated tablets, oval scored tablets, and bisect tablets with immediate-release polymer coating systems based on polyvinyl alcohol or hypromellose.
When Is Roller Compaction Required for High-Dose ARC-0200 Tablets?
Direct compression of ARC-0200 becomes non-viable when the addition ratio must rise above 35.0% w/w because die-fill uniformity is compromised and tablet weight variation exceeds pharmacopoeial limits. Under these conditions, dry granulation by roller compaction is selected as the load-bearing operation. The formulation addition ratio for roller-compacted ARC-0200 granules is set between 40.0% w/w and 60.0% w/w of the dry granule mass; the remaining mass is composed of microcrystalline cellulose, croscarmellose sodium at 2.0% w/w, and a pre-mix of ARC-0200 with hydrophilic fumed silica to reduce sticking on roll surfaces. The dry blend is fed by a screw feeder into a roller compactor with 250 mm roll diameter; hydraulic pressure is held at 60 bar to 90 bar, roll speed at 2.0 rpm to 4.0 rpm, and gap width at 1.8 mm to 2.4 mm. Ribbons are broken and milled through a 1.0 mm stainless-steel screen, producing granules with D50 between 180 µm and 250 µm and fines below 15.0% w/w as measured by USP <786>. After external lubrication with 0.35% w/w magnesium stearate in a diffusion mixer, the granules are compressed on a rotary press to hardness 6 kp to 10 kp. In-process control includes ribbon density measurement by mercury intrusion porosity at 12–18% and granule moisture at ≤2.0% w/w. Compliance references USP <616> for bulk and tapped density, USP <905> for uniformity, USP <711> for dissolution, and 21 CFR 211.110(a) for process validation. Terminal product types are high-dose biconvex tablets, bilayer tablets, and compression-coated tablets.
Capsule Filling Ratios and Tamping-Pin Powder Layering for Two-Piece Hard Shells
With ARC-0200 presented in two-piece hard capsules, the addition ratio is derived from the dose-per-unit divided by the achievable fill weight. For size 0 hard gelatin or HPMC capsules with a practical powder fill weight of 350 mg to 450 mg, API addition ranges from 5.0% w/w for a 20 mg dose to 25.0% w/w for a 100 mg dose; higher doses may require size 00 capsules or a pellet-filled presentation. A tamping-pin capsule filler is preferred over dosator equipment when the ARC-0200 blend exhibits bulk density 0.42 g/mL to 0.55 g/mL because the tamping-pin system tolerates wider particle size distributions. The powder bed is maintained at 12 mm depth, and five tamping cycles at 10 mm pin depth are applied to densify the slug before ejection into the lower capsule body. Fill weight variability is controlled to ±3.0% RSD for capsules above 350 mg fill weight; in-line checkweighing at 300 cpm rejects any capsule outside ±2.5% of target. The filled capsules are sealed with a hydroalcoholic banding solution, then de-dusted and metal-checked. Release testing is governed by USP <905> uniformity of dosage units, USP <701> disintegration with water at 37°C, and USP <711> dissolution using apparatus 1 at 100 rpm for gelatin capsules. Terminal product types are immediate-release hard gelatin capsules, HPMC vegetarian capsules, and enteric-coated capsules when a methacrylic acid copolymer film is applied to the capsule shell.
Granulation of ARC-0200 into oral granules for unit-dose sachets is undertaken when the finished dosing route must bypass swallowing difficulties in pediatric and geriatric populations; the route also supports flexible dose adjustment by dispersing the granule fraction in a fixed volume of water. In this format, the API addition ratio is expressed on a per-gram basis: 2.5 mg/g to 50.0 mg/g of dry granule mass, corresponding to dose labels from 5 mg to 200 mg per sachet at sachet fill weights of 1 g to 4 g. ARC-0200 is first dispersed in a povidone binder solution at 3.0% w/v together with mannitol and hydroxypropyl cellulose; the dispersion is transferred into a high-shear granulator and processed at impeller speed 400 rpm for 90 s, followed by chopper speed 1,000 rpm for 30 s to eliminate oversized agglomerates. Wet mass is discharged through a 6 mm mesh into a fluid-bed dryer with inlet air temperature 65°C and air flow 1,200 m³/h; drying proceeds to a loss-on-drying endpoint of 1.5–2.5% w/w. Dried granules are sieved through 0.8 mm and 0.2 mm screens, and the yield fraction between these screens is retained for filling. Compliance for oral granules includes USP <711> dissolution after dispersion, ICH Q3B for degradation products, and 21 CFR 211 subpart F process controls. Terminal product types are single-dose sachet granules, screw-cap bottles of granules for oral suspension, and double-chamber sachets containing buffered solvent.
If ARC-0200 Is Formulated as a Terminally Sterilised Injectable, the Tonicity and pH Design Space Must Be Locked Before Scale-Up
For parenteral administration, ARC-0200 is compounded in a 316L stainless-steel vessel under ISO 14644-1 class 5 unidirectional airflow with personnel intervention restricted by closed transfer ports. The addition ratio for a terminally sterilised aqueous solution is 2.5 mg/mL to 25.0 mg/mL active; final tonicity is adjusted to 280–320 mOsmol/kg with sodium chloride or mannitol, and pH is maintained between 5.5 and 7.0 using a 10 mM phosphate or citrate buffer system. Oxygen-sensitive batches are overlaid with nitrogen at 0.5 bar positive pressure throughout compounding and filling. Transfer of the API solution employs a maglev centrifugal pump without mechanical seals, which eliminates frictional particle shedding during recirculation through a 0.22 µm polyethersulfone sterilising-grade filter; filter integrity is tested before and after filling by bubble point per ASTM F838-20. Terminal sterilization by steam autoclave at 121°C for 15 min is permitted only after thermal mapping demonstrates ≤ 0.5°C excursion across the load; if pH drift exceeds 0.2 units during validation, the batch is converted to aseptic filtration instead of terminal sterilization. In-process controls include bioburden below 10 CFU/100 mL before filtration and endotoxin below 0.5 EU/mL. Compliance for the finished injection references USP <1>, USP <71>, USP <85>, USP <788>, and 21 CFR 211.94(b) container closure systems. Terminal product types are single-dose Type I glass vials, prefilled syringes with siliconized glass barrels, and co-packaged diluent syringes.
The Primary Drying Shelf Temperature Must Remain Below the Collapse Threshold
Where aqueous instability precludes ready-to-use injection, ARC-0200 is freeze-dried as a sterile cake. The formulation addition ratio is 10 mg to 50 mg API per 5 mL Type I glass vial, co-dissolved with mannitol and sucrose at a 1:1 to 1:3 w/w ratio to bulk solids; total solid content is held between 3.0% w/v and 8.0% w/v. The solution is filtered through a 0.22 µm sterilising filter, filled at 5 mL per vial under ISO 14644-1 class 5 conditions, and partially stoppered with bromobutyl closures. Lyophilisation is performed in a shelf freeze dryer with freezing ramp −1.0°C/min to −45°C, primary drying at shelf temperature −25°C and chamber vacuum 80 µbar, and secondary drying at 35°C for 6 h. Collapse temperature is pre-determined by freeze-dry microscopy; if the product temperature exceeds the collapse temperature by 1.0°C during primary drying, the cake voids collapse and reconstitution time rises above 120 s. The finished vials are sealed under vacuum and inspected for meltback, shrinkage, and particulate contamination. Water content is controlled by USP <921> with an acceptance limit of ≤1.0% w/w. Compliance is governed by USP <1>, USP <71>, and ISO 13408-1:2008 aseptic processing of health care products. Terminal product types are lyophilized powder in single-dose vials, lyophilized powder with sterile diluent prefilled syringes, and solvent-transfer device kits.
Competitive ARC-Series Maglev Pump-ARC-0200 Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable prices that fit your budget—flexible terms and customized quotes for every order.
For samples, pricing, or more information, please contact us at +8618963613625 or mail to sales10@ascent-chem.com.
We will respond to you as soon as possible.
Tel: +8618963613625
Email: sales10@ascent-chem.com
Get Free Quote of Ascent Petrochem Holdings Co., Limited
Flexible payment, competitive price, premium service - Inquire now!
- ARC-Series Maglev Pump-ARC-0200 Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is manufactured under an ISO 9001 quality system and complies with relevant regulatory requirements.
- COA, SDS/MSDS, and related certificates are available upon request. For certificate requests or inquiries, contact: sales10@ascent-chem.com.
The ARC-Series Maglev Pump ARC-0200 Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is a bearingless, sealless centrifugal pump configured for closed transfer of active pharmaceutical ingredients and process intermediates across oral solid dosage, oral liquid, and injectable manufacturing lines. The unit is not a positive-displacement pump; it moves fluid through a levitated impeller driven by an integrated magnetic field, so there is no rotating shaft seal, no shaft, no seal flush, and no mechanical bearing in the wetted product zone. This design removes the seal wear particle source and the lubricant contamination path present in conventional mechanical-seal centrifugal pumps. Product-contact surfaces are specified in 316L stainless steel with an electropolished surface finish in the range of Ra 0.4 µm to Ra 0.6 µm, consistent with ASME BPE Table SF-2.5 for high-purity bioprocess equipment. The ARC-0200 Pharma Grade API variant is intended for services such as binder and solvent transfer into wet granulators, milled granule slurry transport, coating-suspension supply to tablet coating pans, oral suspension and solution transfer, and injectable-grade liquid transfer upstream of sterile filtration. The specific flow-head envelope, net positive suction head required, and maximum solids content for the ARC-0200 must be obtained from the manufacturer’s certified pump curve. Published independent performance data for this exact configuration are limited, and process sizing based on generic centrifugal pump curves is not appropriate for sterile or high-potency API service.
In tablet and capsule manufacturing, the pump’s function is rarely isolated from weight control. A transfer pump that delivers an irregular flow can produce surge in a holding tank, fluctuating pressure at a spray nozzle, or inconsistent feed to a downstream granulator. Because the ARC-0200 is a centrifugal device, it produces continuous discharge rather than the discrete cavity movement of a rotary lobe or peristaltic pump. This operating characteristic is relevant when the pump feeds a binder solution through a nozzle in a fluid-bed granulator, where binder flow pulsation has a direct effect on droplet size and granule size distribution. Granule size distribution is typically evaluated by sieve analysis using USP <786> methods or equivalent ASTM E11 test sieves. The ARC-0200 is therefore operated under variable frequency drive control, with flow set by impeller speed and pump curve pressure, not by a fixed displacement volume. The absence of seal friction and shaft wear reduces the addition of subvisible particulate matter into product-contact liquids, which is an advantage when a tablet or capsule process is later scaled to injectable-grade cleaning requirements. However, the ARC-0200 is not a high-viscosity lobe pump; if the process stream is a paste-like granulation mass or a suspension with yield-stress behavior, the pump’s hydraulic performance may be unsuitable, and a positive-displacement device should be evaluated.
What Distinguishes the ARC-0200 From Peristaltic, Air-Operated Diaphragm, and Sealed Centrifugal Pumps?
The primary difference is the removal of the shaft seal and mechanical bearing from the product-contact zone. In a sealed centrifugal pump, the shaft penetrates the pump housing, and the mechanical seal is a wear point that requires a clean flush or a double-seal buffer. Seal wear can release carbon, silicon carbide, or elastomer particles into the process. In the ARC-0200, the impeller is suspended by magnetic fields inside the pump head, and torque is transferred without a rotating shaft. There is no seal flush bleed, no buffer fluid, and no bearing lubricant in the product zone. Compared with a peristaltic pump, the ARC-0200 avoids cyclic tube compression; peristaltic tube failures are a documented production-scale risk in long-duration oral liquid transfer, and tube spallation generates particulate contamination that must be removed downstream. Compared with an air-operated double-diaphragm pump, the ARC-0200 avoids compressed air exhaust, diaphragm rupture, and check-valve impact; air-operated diaphragm units typically produce pulsating flow and require a pulse dampener. Compared with a rotary lobe pump, the ARC-0200 generally has fewer product-swept dead zones and better direct CIP impingement, but rotary lobe pumps handle much higher viscosities and larger soft solid particles. The ARC-0200 should not be selected for abrasive slurries or hard particles above manufacturer-defined limits because impeller erosion resistance has not been independently characterized with a standard such as ASTM G75 in published literature for this model.
Production-scale use of magnetically levitated bearingless pumps in biopharmaceutical manufacture has shown that the main failure modes shift from shaft-seal leakage to electronic controller faults, rotor stall, and heat accumulation at low flow. The ARC-0200 therefore requires a dedicated controller with alarm outputs for levitation status and casing temperature. A loss of electrical power or a controller fault will stop the rotor; if the pump is feeding a tablet coater or a granulator, this can interrupt the batch. The control system should include a flow or pressure sensor downstream and an interlock to stop the process if pump discharge falls below the setpoint. This is different from an air-operated diaphragm pump, which can be stopped and restarted by the operator without an electronic drive. The ARC-0200’s dependency on a controller is an operational boundary that must be addressed in the automation strategy.
When the ARC-0200 Is Installed in a Wet Granulation, Coating, or Oral Suspension Transfer Line
Wet granulation transfer lines require the pump to deliver binder fluids, drug suspensions, or slurry-like granule suspensions without excessive aeration. Air entrainment in a binder solution can create foam in a spray system and reduce the uniformity of liquid distribution across the granulator powder bed. The ARC-0200’s sealless pump head, when installed with a closed feed tank and an appropriate suction line, removes the seal air-ingress path that may be present in a packed-gland centrifugal pump. The pump must be mounted with adequate net positive suction head; the NPSHR value from the manufacturer’s certified curve must be checked against the system NPSH available at the highest operating temperature and lowest tank level. For coating suspension lines, the pump supplies a liquid dispersion to a spray manifold. Discharge pressure stability is important because a drop in pressure at the nozzle can alter droplet size and coating film formation. Coating uniformity is measured by weight gain and dissolution performance using compendial methods such as USP <711>. The ARC-0200 is used only for transfer; it is not a homogenizer and does not reduce particle size. If the suspension contains particles larger than the manufacturer’s maximum solid clearance, the pump should be protected by an upstream strainer, but the strainer may change the particle size distribution and must be validated as part of the product.
For oral solution and suspension manufacturing, the ARC-0200 can be installed between a mixing vessel and a holding tank or filling machine. The product-contact surface finish and electropolished stainless steel construction are selected to reduce microbial adhesion and residue retention. The pump is designed to be drained by gravity in most orientations, but actual drainability depends on the installed orientation, inlet and outlet port geometry, and hold-up volume. Hold-up volume should be determined during installation qualification, because residual liquid volume in the pump can be a critical process parameter for potent API changeover. The manufacturer’s installation drawing should be used to identify the lowest point and to confirm that the casing drains fully. Published data for this specific configuration are limited; therefore, hold-up volume and drainability must be measured on the actual skid.
Clean-In-Place Performance Boundaries and Riboflavin Verification for the ARC-0200
The ARC-0200 is designed for cleaning-in-place rather than manual disassembly in campaign service. Cleanability is relevant because pharmaceutical equipment used in multi-product oral and injectable lines must be cleaned according to written procedures under 21 CFR 211.67. The pump’s sealless, bearingless construction removes a seal chamber and shaft cavity that in sealed pumps can retain soil. CIP fluid should be supplied at a velocity sufficient to achieve turbulent flow in the adjacent piping; for sanitary stainless steel circuits, a target of at least 1.5 m/s in the pipe and pump casing is commonly applied, but the actual flow required depends on the rated casing volume and the CIP supply pump. Riboflavin coverage tests, often performed with 0.2 g/L riboflavin solution followed by ultraviolet inspection, may be used to document spray coverage of the ARC-0200 pump head and its ports. If the pump is installed in a dead-leg position, a separate spray ball or direct-flow CIP loop may be required. Steaming-in-place, when specified for injectable service, is conducted with saturated pure steam at 121°C for a duration determined by the validated thermal history; the pump’s rotor and housing materials must be evaluated for thermal expansion and steam compatibility. The manufacturer’s temperature and pressure limits for SIP must not be exceeded.
For injectable transfer, the ARC-0200 is positioned upstream of the sterilizing-grade filter. The pump itself is not a sterilizing device and is not a substitute for a final 0.22 µm sterilizing-grade membrane filter. The filter should be integrity-tested according to the filter manufacturer’s method, such as ASTM F838-20 for bacterial retention validation or an equivalent compendial method. In service, the pump discharge pressure should remain below the maximum allowable differential pressure of the downstream filter; this value is filter-specific and is provided by the filter manufacturer. The pump’s contact surfaces, after cleaning, should be rinsed with Water for Injection and sampled for conductivity and total organic carbon according to USP <643> and USP <645> where applicable. Particulate matter in cleaning rinse samples may be assessed against limits derived from USP <788> for injection products. The ARC-0200 Pharma Grade API configuration does not automatically confer sterility or depyrogenation; it provides a cleanable product path that must be integrated into a validated sterilization and sanitation strategy.
Pharmaceutical fluid-contact compliance for the ARC-0200 is summarized in the matrix below.
| Requirement | Reference standard or regulation | ARC-0200 configuration point |
|---|---|---|
| Equipment design and construction | 21 CFR 211.65 | 316L stainless steel product-contact surfaces; no exposed shaft seal |
| Equipment cleaning and maintenance | 21 CFR 211.67 | CIP-compatible, drainable casing orientation; documented hold-up volume validation |
| Surface finish designation | ASME BPE Table SF-2.5 | Electropolished Ra 0.4 µm to Ra 0.6 µm |
| Elastomer/plastic fluid contact | USP <87> and USP <88> | Supplier documentation should confirm biological reactivity classification for any gasket or O-ring used in liquid contact |
| Steam-in-place thermal exposure | USP <1229.4> or site thermal validation | Material and rotor must be rated for saturated steam 121°C or higher if SIP is used |
| Final sterilizing filtration interface | ASTM F838-20 | ARC-0200 located upstream of 0.22 µm membrane filter; filter integrity testing required |
| Rinse water quality | USP <643>, USP <645> | Post-cleaning TOC and conductivity sampling of pump rinse |
The following table compares operating characteristics without ranking the ARC-0200 as a general-purpose replacement.
| Parameter | ARC-0200 maglev centrifugal | Sealed centrifugal with mechanical seal | Peristaltic | Air-operated double-diaphragm |
|---|---|---|---|---|
| Product-contact wear source | No shaft seal or bearing; rotor levitation | Mechanical seal faces and elastomers | Flexible tube compression | Diaphragm and check valves |
| Pulsation | Low when operated within preferred operating region | Low | High | High; pulse dampener often required |
| CIP drainability | High; no seal cavity; drain orientation dependent | Moderate; seal and stuffing box dead leg | Moderate; tube change required | Moderate; check-valve and manifold dead volumes |
| High-viscosity capability | Limited; centrifugal | Limited | Moderate | Moderate to high |
| Dry-run tolerance | Manufacturer-specific; published data for this model limited | Not generally recommended above seconds | Moderate but tube heats | Moderate but diaphragm may wear |
The ARC-0200 is specified for pharmaceutical-grade liquids. It should not be used with strong oxidizing acids, abrasive crystal slurries, or solvents that are incompatible with 316L stainless steel and the specific elastomers. Compatibility data for the pump’s gasket and O-ring materials should be obtained from the supplier. In high-potency API service, the pump should be drained and cleaned before operator exposure, and the installation should include closed transfer to a containment isolator if required by the compound’s occupational exposure limit. The product-contact surfaces are not passivated in perpetuity; passivation may degrade after repeated exposure to high-temperature alkaline CIP media or acidic cleaners. Re-passivation intervals should be defined by the site’s stainless steel maintenance program.
