When buying medical supplies and pharmaceuticals one deems receptacles, containers and holders to be of the utmost quality and the cleanliness associated with this environment to be nothing less than consistently excellent.
Astrapak’s world-class pharmaceutical production at Plastop KZN in Prospecton, KwaZulu-Natal, is in full operation following the completion of the state-of-the-art cleanroom – a crucial aspect of pharmaceutical packaging production. The ISO-6 cleanroom provides a solid platform for Astrapak to further explore the competitive Pharmaceutical sector and to expand its record of excellence in quality in this market.
Originally operating out of the Plastop Bronkhorstspruit plant, the establishment of the brand new cleanroom in Prospecton has seen an increased level of sanitation and offers increased functionality and procedures in terms of cleanroom formalities and access points into and out of the room. Personnel enter and exit the cleanroom through airlock chambers and are required to wear a full-bodied one-piece suit, hairnet and booties that are specially designed to trap contaminants.
Plastop KZN Cleanroom Project Coordinator, Douglas Slogrove, said: “The cleanroom has been successfully implemented and surpassed our target of ISO7 – we are currently ISO6 which is one step better. It is now commissioned and functioning as a supplying and manufacturing cleanroom centre, from bagging the finished product straight off the production line and radiation dot setup right through to batch control. The document control is phenomenal.”
The quality levels that the Pharmaceutical market demands include precision and attention to detail in all respects no less than with regards to the use of a cleanroom. The mark of quality of cleanrooms is deemed as successful by measuring the dust particles in the air inside the cleanroom. Pressure in the cleanroom is driven by HEPA (High Efficiency Particulate Air) filters that trap particles that are 0.3 micron and larger in size, making sure that the cleanroom meets the required certification levels set by the International Organisation for Standardisation (ISO).
The ultra-clinical environment of pharmaceutical packaging manufacture requires that there are minimal dust particles in the air where the plastic product is manufactured and finally packaged for delivery to the customer. To achieve this, the ISO-6 cleanroom has a portable workstation where the completed product drops into a chute directly from the production line for final preparation. The Laminar Flow hood directly above the chute has a quality control of ISO-5, and it is here that the final product is triple-bagged for shipping. ISO-5 carries far less dust particles per section of air than ISO-6.
The dedicated personnel at Plastop KZN have been specifically trained on how to optimally operate in the cleanroom, undergoing extensive training in contamination control in the specialised environment.
This advancement and improvement in technology and service, driven from the highest level in Astrapak, presents Plastop KZN as a centre of excellence in the Injection Blow Moulding (IBM) sector in South Africa primarily focussed on the pharmaceutical industry.