Batch Cockpit>BATCH-2024-05-21-001

Sterile Batch Release Cockpit

In Progress
BATCH-2024-05-21-001Product: mAb-20150 mL VialPlanned Fill: 12,000 Vials
Preparation
Completed
Equipment Setup
Completed
Media Fill
Completed
Pre-Production
Completed
Production
In Progress
Post-Production
Pending
Batch Review
Pending

Batch Summary

Batch IDBATCH-2024-05-21-001
ProductmAb-201 (贝伐珠单抗生物类似药注射液)
Fill Volume50 mL
ContainerType I 硼硅玻璃注射剂瓶 (西林瓶)
Planned Fill12,000 Vials
Filled to Date7,200 Vials (60%)
Start Time2024-05-21 08:15
Elapsed Time04:35:12
StatusIn Progress

Particle Monitor

Current Reading 10:24:35
Within Limits
≥ 10 µm1
≥ 5 µm3
≥ 2 µm12
≥ 1 µm65
(Counts / m³)
NNEESESSWWNW
Worst Sector
SE
Trend (15 min)
Stable
Limit
≤ 1,000 counts/m³

Glove Integrity

P1
P2
P3
P4
All Ports Sealed
Port 1
0.01
mbar
Port 2
0.02
mbar
Port 3
0.01
mbar
Port 4
0.02
mbar
Test Method: Pressure Hold
Last Test: 10:20:15

Environmental Conditions

ISO ClassificationISO 5 / Grade A
Temperature20.6 °C
Relative Humidity34.2 %RH
Differential Pressure+15 Pa
Air Changes per Hour> 245
StatusWithin Limits

Critical Alarms

1
Particle Monitor — ≥ 2 μm
10:24:35
SE sector above alert limit (SE 扇区在加塞补料瞬间测得 88 counts/m³，未突破纠偏限度)
Door Interlock
10:24:20
Closed (传递舱与 A 级区双门联锁自检正常锁定，压差梯度保持 +18 Pa)
Media Fill Pump
10:23:58
Running (在线蠕动泵运行转速平稳，管路无剪切气泡与滴漏)

Batch Values

Line Speed120 vials/min
Fill Volume (Avg.)50.1 mL
Fill Volume (RSD)0.35 %
Stopper Load98.7 %
Pass Rate99.2 %

Quality Gates

Media Fill AcceptancePassed
Equipment ReadinessPassed
Environmental MonitoringPassed
Glove IntegrityPassed
In-Process ControlsIn Progress
Last updated: 10:24:40
All times shown in local cleanroom standard time