WHO ARE WE

Biotec Solutions Ltd. has over 20 years of enriched experience in the supply of pharmaceutical manufacturing, packaging machinery and laboratory equipment including specialized stability study chambers to NZ and AUS market. To cater for the needs of our customers more efficiently, Biotec is now proudly releasing this purpose-built leading edge “Contract Stability Samples Storage” facility to provide consistent, reliable storage conditions for the customers to help reach their goals.

OBJECTIVES

  • Customers who cannot justify financially and / or strategically the short-term or long-term commitment towards the investment for the stability chambers.
  • Testing Laboratories who want to focus on a more profitable business of testing and would like to outsource the storage side of the stability program.
  • A backup stability storage for customers who have their own stability samples storage facility but run out of space due to a sudden surge in storage space requirements.
  • A contingency plan for the customers whose stability chambers are damaged by unforeseen environmental catastrophes, major utilities failure and require an emergency requirement for the storage of stability samples.

CUSTOMERS

  • Human & Vet Pharmaceuticals.
  • Nutraceuticals.
  • Food & Dairy Industries.
  • Cosmetics & Toiletries.
  • Testing and R & D Laboratories.
  • Biosciences and Genetics.

PRODUCTS

  • Tablets / capsules / soft gels - bottles.
  • Tablets / capsules / soft gels - blister packs.
  • Nutritional supplements powder - sachets / pouches / cans.
  • Dairy supplements bulk packs / cans / bags (up to 25 kg).
  • Creams / ointments / liquid orals / gels bottles & tubes.
  • Bulk liquid buckets / powder / pails (up to 225 kg).
  • Reference standards / biological samples / medical devices.
  • Injectables, infusion vials, syringes, ampoules.

FACILITY CHAMBERS STORAGE CAPABILITIES

Stability Storage facility constitutes a combination of both Walk-in and standalone chambers in line for over 12 different popular types of stability temperatures and RH conditions as below.

Intermediate & Long-Term Accelerated Storage Conditions

A) Immediate & Long-Term Accelerated:

  • 25⁰C / 60% RH
  • 30⁰C / 65% RH
  • 40⁰C / 75% RH
  • 30⁰C / 75% RH
  • 37⁰C / 75% RH   

B) Temperature Only:

  • Freezer: - 20 ⁰C
  • Thaw: -20 ⁰C to 60 ⁰C
  • Cooling: 2 ⁰C to 8 ⁰C
  • 3 Incubators: 5 ⁰C to 60 ⁰C
  • Photo Stability

C) Miscellaneous Storage Conditions:

  • Custom specific storage conditions for short term
  • Additional storage space as a contingency
  • (For temperatures above)
  • 40 ⁰C / not more than NMT 25% RH
  • 25 ⁰C / 40% RH

SALIENT FEATURES OF STABILITY STORAGE FACILITY

  • High quality chambers with high accuracy and uniformity.
  • Qualified and validated (DQ / IQ / OQ / PQ) chambers.
  • Meets ICH guidelines ICH Q1A(R2).
  • PLC Controlled with 24 x 7 real-time remote monitoring.
  • 21 CFR Part 11 compliant – Web-based ICDAS 2.1 software.
  • Alarm system with camera surveillance for security.
  • Latest temperature and relative humidity testing tools.
  • Data storage, audit trail reports as per GMP guidelines.
  • Complete secrecy of product and documentation.
  • In-house technical experts and quick efficient back up.
  • Standby utilities for uninterrupted supply for minimal
  • downtime.
  • Storage contingency management plan in case of breakdown.
  • Samples receival and timely dispatch through courier service.
  • Insurance against mechanical and electrical failure damage.