CleanFlex®

With our class 5 clean room production facilities in accordance with DIN EN ISO 14644-1 (=class 100 FED-STD 209 E), we offer low-germ and low-particle production of our packaging material, guaranteeing "safety via extremely pure quality". 

This specifically includes:

• Single-wound and tubular films
• Open-mouth and side gusseted mitred sealed bags
• Bottle-shaped bags
• Multiple-ply bags (Two- or three-ply-bags)
• Laminated aluminium bags with three sealing seams
• Tyvek® / HDPE bags with three side seals, autoclavable
• Packaging with DMF

Tailor-made for customer wishes raw materials according to FDA and LFGB can be used and fixed with unique material numbers. Additionally all production and quality related processes are GMP-friendly designed at all levels. The advantages to you are clear:

• Low germ and low particle packaging
• The finished products retain the purity in which you have invested.
• Protection against external influences following production.
• No contamination of your own clean room facilities.

Use of CleanFlex® therefore ensures a high level of product safety and quality by adhering to the clean room chain from the start of production until the product reaches your customer.

Extrusion, printing and conversion are integrated into our complete clean room environment. Laminating machines round off the machinery used for CleanFlex® products. This enables us to produce individual packaging material for your special pharmaceutical, medical or IT industry requirements.

 PE films, converted packaging material or laminates manufactured from diverse materials (PET / ALU / PA) can be supplied as finished products – in addition, we are always open and committed to new developments and projects. The objective of our strict customer orientation is to be the preferred partner in your industry.

Material:

• All polyethylene types, also in combination with additives.
• All commercially available laminate materials.

Products:
E.g. clean room clothing, mouth guards, masks, medical gloves, silicon chunks and wafers, electronic and micromechanical components, food additives, etc.

Sterilisation processes can be arranged on request.

 Indicator:
Are implemented on request.
 

The combination of a PE bag with Tyvek® material enables the product to be sterilised using water vapour through the surface of the packaging material. As a rule, the front is manufactured from Tyvek® and the rear from HDPE; however, full Tyvek® packaging material is also possible, as is the integration of a Tyvek® window.

 Plastic and rubber bungs can be sterilised using water vapour in the bag, without its subsequently having to be re-opened. The seals can be used directly.

By changing colour, a printed-on sterility indicator confirms that water vapour sterilisation has taken place.

 (Tyvek® is a registered brand name of DuPont.)

Material:

• Tyvek® of Du Pont
• HDPE
• LDPE

 Products:
Plastic and rubber bungs, injection-moulded plastic parts, seals etc.

The bags have been specifically designed for water vapour sterilisation after filling. However, gamma irradiation is also possible. 

Indicator:
Printed-on sterility indicators or other indicator labels are also available.
 

Active pharmaceutical substances, in particular, are still filled into and stored in expensive aluminium cans, involving considerable logistical effort. Specifically, cleaning the cans after use, transportation and storage of the empty cans cause significant costs. 

Our three-fold packaging will facilitate transfer and offers major cost advantages due to the fact that it is disposable. Cross-contaminations are ruled out thanks to the non-returnable principle. Tertiary, secondary and primary packaging in a flexible system as a tailor-made solution from BISCHOF + KLEIN. 

Purity – Safety – Economy: 3-in-1
 

Material:

• Laminated aluminium liner
• PE flat liner manufactured from 100 % LDPE
• PE bottle shaped bag manufactured from 100 % LDPE
• EP, USP and FDA approval
• A DMF is stored with the FDA.

Products:
Active pharmaceutical substances such as penicillin, antibiotics and others.

Sterilisation processes can be arranged on request.

 Indicator:
Each packaging unit can be equipped with a special indicator sticker.
 

Their simple appearance is misleading, as the laminated aluminium bags with three sealing seams are high-barrier packaging products. Thanks to their high water vapour and oxygen barrier, they offer their contents optimal protection against moisture and oxygen. They additionally offer absolute light protection and the option of vacuum-packing their contents.

 At present, there are no alternatives to this high-performance package on the market. Transparent laminates, e.g. with polyamide or EVOH, can also be processed. If your product also demands special protection, talk to us about your requirements.

Material:

• Aluminium laminates
• Transparent compound (with PA or EVOH, etc.)

 Features :

• Light protection
• Moisture protection
• Oxygen barrier
• Aroma protection, aroma barrier
• Sealable and evacuatable

We have been producing CleanFlex® bottle-shaped bags for a number of years, with constantly growing experience and increasing improvements. For example, special sealing radii and cut-and-finish seams have led to important development steps.

 With their sealed, shaped shoulder, these bags are used wherever compatibility with a filling or pouring spout has to be guaranteed to achieve dust-free filling/emptying. One additional advantage is the optimal, complete emptying ensured by the diagonal seals around the neck. This is highly-regarded, particularly when handling powdered, highly-sensitive and expensive products.

 The bottle-shaped bags therefore offer ideal adaptability, in isolator production for example, whilst simultaneously providing high capacity in a compact format.
 

Material:

• 100 % LDPE
• EP, USP and FDA approval
• A DMF is stored with the FDA.

 Products:
Pharmaceutical active substances such as penicillin, antibiotics and others.

Sterilisation processes can be arranged by B+K in accordance with customer requirements. For example, gamma irradiation.

 Indicator:
Each packaging unit can be equipped with a special indicator sticker. The change in the indicator's colour confirms that sterilisation has taken place.

For special customer requirements, e.g. bagging active pharmaceutical substances, Bichof + Klein's multi-ply bags offer a packaging solution tailored to users' individual wishes. The co-ordinated, individual packaging materials can be effortlessly placed inside one another by the user or purchased as pre-assembled combination packaging from B+K - ready-to-use by the customer.

 The multi-ply bags are therefore ideal for use in bagging high-purity products, particularly in a graduated clean room environment. Always protected by clean packaging material – bag by bag – from air lock to air lock – up to the high-purity primary packaging.
 

• 100 % LDPE
• EP, USP and FDA approval.
• A DMF is stored with the FDA.

 Products:

Sterilisation processes can be arranged by B+K in accordance with customer requirements. For example, gamma irradiation.

 Indicator:
Each packaging unit can be equipped with a special indicator sticker. The change in the indicator's colour confirms that sterilisation has taken place.