9.77 m² shelf area, 200 kg/batch ice capacity, up to 42,900 vials/batch
Automatic loading/unloading (ALUS/RBR) at 200 vials/min inside ORABS barrier
GAMP5 & 21 CFR Part 11, CIP/SIP, 316L product contact
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Lyophilizer with Automatic Loading/Unloading System (ALUS) & ORABS Barrier
AIPAK Engineering lyophilizer system (Model FD-10SC-RBR) combines a production freeze-dryer, an automatic loading/unloading system (ALUS/RBR) and an ORABS barrier. Filled and half-stoppered vials are automatically loaded from the filling & stoppering machine onto the lyophilizer shelves; after freeze-drying and full-stoppering, the fully-stoppered vials are automatically unloaded to the capping machine. The entire loading/unloading process is completed inside the ORABS barrier, isolating personnel from the aseptic path.
The lyophilizer consists of chamber, condenser, refrigeration, vacuum, heat-transfer, hydraulic, pneumatic, CIP/SIP, venting, electrical and control systems. It handles 2–50 ml vials with a batch capacity of up to 42,900 vials (Φ16 mm) and 200 kg ice capacity, under GAMP5 and 21 CFR Part 11 compliant control. The transfer system can be programmed to bypass the lyophilizer when required.
Lyophilizer system example:
Chamber & Shelves
Rectangular 316L chamber (Ra ≤ 0.4 µm), design pressure −0.1 to 0.15 MPa, design temp 128 °C, coving corners with no crevices for product contact. 316L shelves, total net shelf area 9.77 m² (10+1 upper radiant shelf), shelf spacing 120 mm, shelf temperature uniformity ≤ ±1 °C (−40 / 0 / +40 °C unloaded), temperature range −55 to +80 °C.
Condenser
Horizontal-cylinder condenser, 316L internal (Ra ≤ 0.4 µm), maximum ice capacity 200 kg/batch, minimum coil temperature −75 °C, with de-icing spray balls and illuminated sight glass.
Refrigeration System
Bitzer S6G-25.2Y compressors (×2), CFC-free R404A refrigerant, water-cooled condensers, Danfoss valves. Shelf cooling +20 → −40 °C ≤ 60 min; condenser cooling ≤ 30 min (empty load).
Vacuum System
Edwards E2M80 vacuum pumps (×2) + Edwards EH500 Roots pump, final vacuum 1 Pa, evacuation 1 atm → 10 Pa ≤ 30 min, leakage rate 3×10⁻³ Pa·m³/s, Pirani vacuum gauges.
Hydraulic Stoppering
Hydraulic shelf stoppering, force 0–1.0 bar adjustable, with linear position sensors and 316L bellows sealing — full-stoppering after freeze-drying.
ALUS/RBR Automatic Loading/Unloading
Automatic loading/unloading system (ALUS-960-1200-RBR): vials collate on the buffer platform, then a pusher loads them onto the shelf via the engagement system; after the cycle, a pusher on the lyophilizer unloads them to capping. Loading/unloading speed 200 vials/min (Φ22 mm), constant loading height 900 ± 10 mm.
ORABS Barrier
Open Restricted Access Barrier System (ORABS-01) enclosing the loading/unloading zone, with HEPA filtration and cleaning/decontamination — isolating personnel from the aseptic path. Standard height 2600 mm.
Lyophilizer System Features:
- Integrated system: lyophilizer + automatic loading/unloading (ALUS/RBR) + ORABS barrier.
- Automatic loading of filled half-stoppered vials and unloading of full-stoppered vials — personnel isolated from the aseptic path.
- Applicable vial size: 2–50 ml; batch capacity up to 42,900 vials (Φ16 mm) / 22,600 vials (Φ22 mm).
- Total net shelf area 9.77 m² (10+1 shelves), spacing 120 mm.
- Shelf temperature uniformity ≤ ±1 °C; temperature range −55 to +80 °C.
- Condenser ice capacity 200 kg/batch, minimum coil temperature −75 °C.
- Shelf cooling +20 → −40 °C ≤ 60 min; condenser cooling ≤ 30 min (empty load).
- Final vacuum 1 Pa; evacuation 1 atm → 10 Pa ≤ 30 min; leakage rate 3×10⁻³ Pa·m³/s.
- Bitzer compressors, CFC-free R404A; Edwards vacuum + Roots pumps.
- Hydraulic stoppering 0–1.0 bar adjustable, 316L bellows sealing.
- ALUS/RBR loading/unloading at 200 vials/min, constant height 900 ± 10 mm.
- Transfer system can bypass the lyophilizer when required.
- CIP/SIP for chamber, condenser and shelves.
- Main door in service room + slot door in clean room, automatic seesaw slot door with O/M-shaped silicone seals.
- 316L product-contact parts, Ra ≤ 0.4 µm, coving corners, no dead spots.
- ORABS barrier with HEPA filtration and decontamination.
- GAMP5 & 21 CFR Part 11 compliant control; automatic customized lyophilization recipes.
- Split machine structure; humanized touch-screen operation.
- Products customizable to actual customer demand.
Lyophilizer System Technical Specification:
| Item | Specification |
| Lyophilizer model | FD-10SC-RBR |
| ALUS model | ALUS-960-1200-RBR |
| ORABS model | ORABS-01 |
| Lyophilizer size (L×W×H) | 6700 × 1950 × 3700 mm (approx.) |
| Lyophilizer weight | approx. 20,000 kg |
| Vial size range | 2–50 ml vials |
| Batch capacity | 42,900 vials (Φ16 mm) / 22,600 vials (Φ22 mm) |
| Total net shelf area | 9.77 m² (10+1 upper radiant shelf) |
| Shelf spacing | 120 mm |
| Shelf temperature uniformity | ≤ ±1 °C |
| Shelf temperature range | −55 to +80 °C |
| Maximum ice capacity | 200 kg/batch |
| Minimum condenser coil temp | −75 °C |
| Shelf cooling (empty) | +20 → −40 °C ≤ 60 min |
| Condenser cooling (empty) | +20 → −40 °C ≤ 30 min |
| Final vacuum | 1 Pa |
| Evacuation speed | 1 atm → 10 Pa ≤ 30 min |
| Leakage rate | 3×10⁻³ Pa·m³/s |
| Stoppering force | 0–1.0 bar (adjustable) |
| ALUS/RBR loading speed | 200 vials/min (Φ22 mm) |
| Constant loading height | 900 ± 10 mm |
| Product-contact material | 316L, Ra ≤ 0.4 µm |
| Compliance | GAMP5, 21 CFR Part 11 |
| Key configuration | Bitzer, Edwards, Danfoss, GEMU, WIKA, Miyawaki |
Lyophilizer System Video
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