ISO Certification Guide

This is how we create single-use products

1. Introduction

CerCell design together with user and manufacture for user:

  • Customized Single-Use-Bioreactors
  • Customized Single-Use-Fermenters
  • Customized Single-Use-Mixers

for a variety of applications within the pharmaceutical industry and the chemical industry.

The quality of the products focus on the entire process which:

  • adheres to international standards
  • guaranteeing an adequate level of protection against (cross) contamination
  • insuring traceability and conformity

See separate document about Measures.

The following information is the Validation Guide compiled by CerCell to aid user´s of the various Single-Use products through the creation of their own validation procedures (planning, implementation, and documentation.)

2. Quality Assurance

ISO certificate for CerCell can be found on a separate page.

The following is paramount to CerCell:

  • Material Control & Traceability of all raw materials and semi-finished products from the manufacturer
  • Traceability of each individual product from design phase to shipment arrives at customer
  • Product repeatability from Lot-to-Lot

3. Product philosophy

CerCell’s wide range of customizable products are made from a variety of resins and materials. Different products fulfil different requirements depending on customer requirement. Some products are not used for pharmaceutical application and many products are. In general all plastics used are rigid plastics and no film, foil if used are in media contact.

4. Drawing and design

Each SUB and SUF product pass the design phase with CerCell´s design team in collaboration with the user. Based on the “Configurator Tool” the design phase results is a unique customized product with manufacturing code, parts list and associated CAD drawing for user presentation. User testify that the developed product is as expected and goes into manufacturing.

5. Materials used

User can specify most of the materials used to generate the SUB or SUF product. Some products comply with applicable FDA and/or USP and/or ISO standards and for some products it´s not required.

Check out separate document for more detailed information about materials. Some materials has been independently tested and shown to meet or exceed the requirements set by USP, FDA recommendations or ISO regulations.

6. Quality Check

Each SUB or SUF must pass a documented manual quality check to insure conformity with the specific drawing and parts list.

7. Integrity

Each SUB or SUF must pass a documented pressure test to measure the quality of construction and vessel integrity of the finished assembly, including all seals for ports, penetrations, and tube connections.  

Each SUB or SUF must meet the criteria of:

  • pressurized at minimum 100 mBar with sterile air
  • 5 minutes hold time
  • stable pressure maximum 0.5% deviation indicating no-leaks

After each SUB or SUF has passed the integrity test the products is immediately dual PE film bagged.

8. Leachable & Extractable

CerCell jointly with user test relevant materials for influences on various cell lines. Any specifically designed SUB or SUF for user can be offered tested for E&L according to specified requirements by user.

9. Sterility

  • Each light weight SUB or SUF is after dual film bagging irradiated with 2x16 or 4 x 8 kGy before shipment to user. The product is then ready for relevant use right out of the box.
  • Each SUB or SUF is traceable to the specific E-beam irradiation lot.
  • If required a dose mapping for a specific lot can be offered to prove that a specific lot receives adequate irradiation.
  • A certificate example from Sterigenics can be examined under Irradiation Guide
  • Irradiation performed and certified by www.sterigenics.com

The product is then ready for relevant use right out of the box.

Date: April 2016
Version: 1.5