AMPOULE WASHING , STERILIZATION , FILLING & SEALING LINE - Shree Bhagwati Machtech India Pvt Ltd

The equipment specification conform to quality guidelines GAMP4 and supports 21 CFR PART 11 requirements.

We offer following Compact Sterile Ampoules & Vials Processing Line:

Categories: Process & Packaging Machinery, Processing and packaging Machine, Plant, Equipment

Description

SHREE BHAGWATI offers customized plant construction for the pharmaceutical injectable industry demand of Washing, Sterilizing , Filling & Sealing line. A set of machineries are synchronized for the processing of ampoules and vials. Compact installations are particularly economical and flexible in respect of format and product change over. The space saving and energy saving compact installation are clearly laid out and easy to operate with saving in number of operators, less personnel movement in the classified area. The equipment specification conform to quality guidelines GAMP4 and supports 21 CFR PART 11 requirements.

We offer following Compact Sterile Ampoules & Vials Processing Line:

Ampoule Compact line	300
Ampoule Compact line	200
Ampoule Compact line	120
Liquid Vial Compact line	300
Liquid Vial Compact line	200
Liquid Vial Compact line	120
Liquid Vial Compact line	60

The entire line consists of linkage of Vertical Washing Machine, Sterilization Tunnel & Filling and Sealing Machine. All linkage accessories along with filtration skid for water, Filtration sterile filter for main batch liquid, Laminar Air Flow are also supplied along with complete line.

AMPOULE / VIAL WASHING MACHINE

Vials Washing Process:	Ampoules Cleaning Process:
Ultrasonic treatment (optional) • Recycled water (internal and external) • Compressed air (internal) • Purified water (internal) • Compressed air (internal) • WF1 (internal) • Compressed air (internal)	Ultrasonic cleaning • Internal and external cleaning by spraying with Re-circulated water (1-Station) • Internal blow-dry with compressed air (1-Station) • Spraying with Purified water • Internal blow-dry with compressed air • Spraying with WFI (1-Station) • Internal and external blow dry with compressed air (2- Stations)

Vials Working Description:

Ampoules Working Description:

Vials can be fed on to an in feed conveyor or alternatively a turntable from where they are fed to a star-wheel and delivered to a revolving conveying system consisting of 40 or 60 grippers equally spaced. V-grippers are mounted o the circumference of the gripper ring, which rotates around a vertical axis. The horizontal rotation of the vial through 180˚ during the in feed as well as the opening and closing of the grippers is cam-controlled. Vials are passed through the cleaning station upside down. At the individual stations, spray tubes travel is synchronized with vials, then enter the vials whose orifices are exactly centered. The spray tubes follow the continuously moving grippers from the start to the finish of a working station and retract.

Ampoules can be fed directly from trays into the in feed chute. From there, passing under a shower head, they are immersed in he heated ultrasonic bath. In the water bath the ampoules are singled out into reciprocating lanes. The individually positioned ampoules are pushed into the cones of the centering bar by pushers and then fed directly on to the jetting needles. The jetting wheel works intermittently and feeds the ampoules to the jetting stations in the upper section. The ampoules are blown of the jetting needles and lifted into the discharge tray. At this point the ampoules can be either tray or fed directly on to the conveyor belt of the sterilizing tunnel.

*Ampoules*	Max diameter Nos./min	Max height	Capacity	Grippers
	14.75	83	300	60
	14.75	83	200	40
	17.75	102	150	40
	22.5	113	70	26
*Vials sizes*	25	45	300	60
	38	61	200	60
	25	45	200	40
	53	97	120	40
	25	60	120	26
	44	73	80	26

Technical Specifications

Output of the machine

300 Amp/min

16Head

D 10-16mm

12 Head

D 18-25 mm

SALIENT FEATURES

All parts that come in contact with the internal surface of the ampoule/ vial and wash media are made of AISI SS 316L stainless steel.
Other parts are made from engineering plastics, FDA approved or AISI SS 304 stainless steel.
The washing process can be customized to your requirement. Each vial or ampoule is guided through a series of process steps.
Short set up time, fast & simple size change ensures versatility of use for different ampoule/vial
All electronically controlled features of machine can be equipped through PLC with operational data logging system for the documentation of all data relevant to the production

AMPOULE / VIAL STERILIZATION & DE-PYROGENTAION TUNNEL

De-pyrogenation tunnels designed to sterilize and de-pyrogenate glass containers with a continuous process maintaining an ISO 5 environment along the whole length and width of the conveyor belt complying with ISO 14644-1 requirements.
Designed to allow higher outputs in a more compact body and with better control of the process. INTERTECH tunnels are equipped with

Cooling system for the cooling zone.
Sterilizing of the cooling zone.
Automatic air balancing between aseptic and non-aseptic area of the tunnel.
Shutter positioning monitoring and automatic adjustment are some of the options available to meet specific customer requirements.

TECHNICAL PARAMETERS

Sterilizing Temperature – 350 Deg C
Sterilizing Time – 5min to 7 min
Net stripe speed – 50-250 mm/min
Cleanness grade & method – 100 class with vertical laminar flow
Speed – 100 to 300 Ampoules /min.

Technical Specifications
	SBDST 300	SBDST 400	SBDST 450	SBDST 600	SBDST 900	SBDST 1200
Length	2700	3315	2800	2800	3900	4200
Height	2400	2400	2400	2400	2400	2400
Width	1300	1400	1400	1450	1550	2150
Belt width	300	400	400	450	600	1200
Exhaust Air-m3/hr	1347	1845	1845	1244	4448	8227
Installed Power(kw)	38	45	45	29	55	95

SALIENT FEATURES

Each independent filter plenum is provided with filter integrity sample ports.
The equipment’s conveyor net is monitored and alarm status is activated if it operates outside the belt speed set points.
Provision for ports to allow introduction of validation thermocouples in each zone
The tunnel is provided with fully integrated vial flow control logic to allow automatic stops and restarts of the equipment.
All filter modules have differential pressure gauges to monitor pressure. Pressure switches with high and low alarms
When the tunnel is not in use it can be operated in night-mode to save energy while preventing contamination.
The air quantity in whole machine can be set to auto section frequency- conversion balance.
All critical parameters i.e. temp., Fan speed etc. has auto recording facility.

AMPOULES FILLING & SEALING MACHINE

Operation:

Infeed conveyor is fed with ampoules out of magazines or directly from a Sterilizing Tunnel. Ampoules loaded on to a conveyor belt are fed to a screw conveyor in the upright position. The screw conveyor transports the ampoules on to a segment wheel to be carried on to a conveying cradle. The conveying cradle carries eight, six or four ampoules in a group through the stations pre-gassing before filling, filling, post-gassing after filling, pre-heating and heating in the vertical position.

Operations performed are as per below sequence :

Ampoule transport by infeed conveyor, infeed scroll and ampoule transfer into transport rack.
8 ampoules are advanced per machine stroke.
Centering of ampoule necks during gas flushing and liquid filling.
Rotation of ampoules in the pre-heating and heating station.
Elimination of burned-off ampoule tips by clippers and ejection into a separate container.
Discharge of filled and sealed ampoules onto discharge tray.

Liquid Filling Station is with

Filling Manifold.
Eight AISI 316L dosing syringes and eight stainless steel discharge needles.
A choice of electro-mechanical tube pinching valves, or rotary piston.
Micro fine volume adjustment of the syringes for dosing variation.
Ampoule neck centering during filling.
No ampoule – no fill system without machine stop.

Ampoule sealing Station is with

Pre-heating station with adjustable flames and flow-meter for oxygen and combustible gas.
Sealing station with adjustable flames and flow-meter for oxygen and combustible gas.
Ampoule rotation during the pre-heating and sealing cycles.
One set of clippers to eliminate the ampoule tips after sealing and to eject them into a waste container.

The machine performs the following operations:

Ampoule transport by infeed conveyor, infeed scroll and ampoule transfer into transport rack.
8 ampoules are advanced per machine stroke.
Centering of ampoule necks during gas flushing and liquid filling.
Rotation of ampoules in the pre-heating and heating station.
Elimination of burned-off ampoule tips by clippers and ejection into a separate container.
Discharge of filled and sealed ampoules onto discharge tray.

Liquid Filling:

Filling Manifold.
Eight AISI 316L dosing syringes and eight stainless steel discharge needles.
A choice of electro-mechanical tube pinching valves, or rotary piston.
Micro fine volume adjustment of the syringes for dosing variation.
Ampoule neck centering during filling.
No ampoule – no fill system without machine stop.

Ampoule sealing:

Pre-heating station with adjustable flames and flow-meter for oxygen and combustible gas.
• Sealing station with adjustable flames and flow-meter for oxygen and combustible gas.
• Ampoule rotation during the pre-heating and sealing cycles.
• One set of clippers to eliminate the ampoule tips after sealing and to eject them into a waste container.
• Safety valves and pressure reducers with manometer on oxygen and combustible gas circuit.
• Stainless steel hood to extract the fumes created by the flames during pre-heating and sealing, complete with
discharge pipe ready to be connected to a centrifugal aspirator (optional) or to customer’s fumes extraction duct.
• Automatic ampoule discharge onto twin trays.

Technical Parameters
Model	SBIET-8- 300	SBIET-6-250	SBIET-4-150
Output	300 Amp/min	250 Amp/min	150 Amp/min
Electrical Rating	Neutral, 415 volts 3 phase
Main Drive	0,75 kw
Spinning/Conveyor drive	0,12 kw x 2
Flame Extractor	0,37 kw
Ampoule Handing Range	D: 9-18 mm	9-22 mm	9-22 mm
	H: 60-125 mm	60-125 mm	60-125 mm

SALIENT FEATURES

Self-centering grippers for the transport of all ampoule diameters within the size range without the need to change.
Ampoule neck centering during gas-flushing and filling.
Possibility of gas flushing before, during and after the filling.
AISI316L dosing syringes without gaskets.
Drip free adjustment for media of different viscosity. Possibility of direct connection to sterilizing tunnel. No ampoule no filling function.
Full accessibility allows easy maintenance.
Fast change-over due to extremely limited number of parts to be replaced.
Individual micro metric adjustment of the syringes.

Our Domestic Presence:

We manufacturer and supply AMPOULE WASHING , STERILIZATION , FILLING & SEALING LINE to Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Delhi, Goa, Gujarat, Haryana, Himachal Pradesh, Jharkhand, Karnataka, Kerala, Maharashtra, Madhya Pradesh, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Tamil Nadu, Tripura, Telangana, Uttar Pradesh, Uttarakhand, and West Bengal.