Safe And Easy Powder Containment And Transfer

Containment of pharmaceutical ingredients and materials, whether for the protection  of operators, the environment or the product itself, is a continuing priority for the pharmaceutical industry.

Conventional reusable containment and delivery systems can be time-consuming and costly to clean and validate. On the other hand, cheap plastic sacks can be unsatisfactory from a cleanliness, dust generation and materials recovery perspective.

Pall PD2 powder handling bags have been developed to combine the virtues of effective containment and high product recovery with the cost savings and efficiency of single-use technologies. The PD2 film has been developed to allow the bags to  be supplied in irradiated or non-irradiated formats, depending on the application requirements.

Feature	Benefit
100% leak tested	Robust and safe technology for  powder handling applications
Tapered funnel-shaped bag and polyethylene based multi-layer film with a permanent antistatic additive in the contact layer	High product recovery during  operation, typically >99.95%
Flexible, transparent material,  ergonomic handle	Ease-of-use and process visibility
Made in ISO Class 7 cleanroom	Suitable for use in all typical biopharmaceutical applications
Standard sanitary connections in 2 in., 4 in. or 6 in. sizes	Broad connection compatibility and robust powder containment and process integrity
2.5 L to 50 L capacities as standard	Suitable for a wide range of powder handling applications and volumes
125 mL samples available	Off-the-shelf availability for stability studies
Lifting technology available to support powder bags around mixing applications	Can form part of a total processing solution for powder handling around mixing applications
Available in both irradiated and non-irradiated formats	Can be used in applications where powder requires irradiation after filling into the powder bags
3 sterilization grades available: sterile claimed, gamma-irradiated, none gamma-irradiated	Flexible to suit applications requiring different sterilization grade

Applications include contained transfer, storage or shipping of:

• Dry powder media
• Filter aids
• Buffer salts
• Excipients

Technical Specifications

The Pall PD2 powder handling bags are constructed from a polyethylene based multi layer film with a permanent antistatic additive in the contact layers.

The film thickness is 200 micron.

Maximum load: 25 kg/handle

Sterilization Method: Gamma irradiation (maximum 50 kGy)

Supporting Hardware And Single-Use Accessories

To facilitate ease-of-use of the powder handling bags, a range of hardware is available to assist in the powder addition and delivery into a process.

A wide range of single-use accessories is available from Pall Biotech. The main items are highlighted in figure 3 and are referenced with all other accessories in the ordering information section of this datasheet. Single-use accessories include:

Closures: Sanitary clamp, gaskets, caps and plugs to securely close the PD2 powder bag.

Outer Clamps: A variety of pinch clamps to control powder movement within a powder bag.

Filling Liners: Single-use devices to facilitate filling of a powder bag.

Chutes: To extend the connectivity of the powder bag outlets.

 

Table 1

Accessories for powder handling bags1

Size	1. Pinch Clamp	2. Gasket		3a/3b. End Cap		4. Sanitary Clamp
	Non-irradiated	Irradiated	Non-irradiated	Irradiated	Non-irradiated	Irradiated	Non-irradiated
2 in. sanitary outlet	700009CNS	4100142CS	4100142CNS	3a: 4101083S	3a: 4101083NS	700154CS	700154CNS
3 in. sanitary outlet	700119CNS	SC00876S	SC00876NS	3b: FY02445S	3b: FY02445NS	FY02444S	FY02444NS
4 in. sanitary outlet	700119CNS	4100138CS	4100138CNS	3a: 4100136S	3a: 4100136NS	700152CS	700152CNS
6 in. sanitary outlet	700734CNS	4100134CS	4100134CNS	3b: 700603CS	3b: 700603CNS	701076CS	701076CNS

*1Minimum Order Quantity 10 pieces

Quality Standards

 

The Pall PD2 powder handling bags are:

• 100% leak tested

• Manufactured in-house in a controlled environment (ISO 7) under a quality management systems certified to ISO 9000.

A full Validation Guide is available from Pall. The materials of construction of the powder handling bags are compliant with the following USP/Regulations:

• ISO 10993-5 (biological compatibility)

• USP <87> (cytotoxicity)

• USP <88> Class VI (biological reactivity)

• USP <661> (physicochemical tests for plastics)

• BSE/TSE EMEA 410/01